FDA Approvals of Brand-Name Prescription Drugs in 2016

March 2017, Vol 10, Eighth Annual Payers' Guide - FDA News & Updates, Payers' Guide
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The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2016 and are grouped into the following categories:

  1. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications
  2. New Combinations and New Indications
  3. New Dosages, Dosage Forms, Formulations, Delivery Systems, and Patient Populations
  4. New Biosimilars, Blood Products, and Vaccines

1. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications

Adlyxin (NME)
(Lixisenatide; Sanofi-Aventis)
Class/route: GLP-1 receptor agonist; subcutaneous injection
Indication: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Approval date: July 27, 2016

Anthim (BLA)
(Obiltoxaximab; Elusys Therapeutics)
Class/route: Monoclonal antibody; intravenous infusion
Indications: For the treatment of inhalational anthrax in adults and pediatric patients as a result of Bacillus anthracis, in combination with appropriate antibacterial drugs; and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate
Approval considerations: Fast track, orphan drug
Approval date: March 18, 2016

Axumin (NME)
(Fluciclovine F 18; Blue Earth Diagnostics)
Class/route: Radioactive diagnostic agent; intravenous infusion
Indication: For positron emission tomography imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen levels after previous treatment
Approval consideration: Priority review
Approval date: May 27, 2016

Briviact (NME)
(Brivaracetam; UCB)
Class/routes: Anticonvulsant; intravenous infusion, oral
Indication: As adjunctive therapy for the treatment of partial-onset seizures in patients aged ≥16 years with epilepsy
Approval consideration: Patient medication guide
Approval date: February 18, 2016

Cinqair (BLA)
(Reslizumab; Teva)
Class/route: IL-5 antagonist monoclonal antibody; intravenous infusion
Indication: Add-on maintenance treatment of patients with severe asthma aged ≥18 years and with an eosinophilic phenotype
Approval date: March 23, 2016

Defitelio (NME)
(Defibrotide; Jazz Pharmaceuticals)
Class/route: First-in-class anticoagulant; intravenous infusion
Indication: For the treatment of adults and pediatric patients with hepatic veno-occlusive disease with renal or pulmonary dysfunction after hematopoietic stem-cell transplantation
Approval considerations: Fast track, priority review, orphan drug
Approval date: March 30, 2016

Epclusa (NME)
(Sofosbuvir and velpatasvir; Gilead Sciences)
Classes/route: HCV nucleotide analog NS5B polymerase inhibitor and HCV NS5A inhibitor; oral
Indications: For the treatment of adults with chronic HCV infection genotype 1, 2, 3, 4, 5, or 6 without cirrhosis or with compensated cirrhosis; and for those with decompensated cirrhosis, for use in combination with ribavirin
Approval considerations: Breakthrough therapy, fast track, priority review
Approval date: June 28, 2016

Eucrisa (NME)
(Crisaborole; Pfizer)
Class/route: PDE-4 inhibitor; topical ointment
Indication: For the topical treatment of mild-to-moderate atopic dermatitis in patients aged ≥2 years
Approval date: December 14, 2016

Exondys 51 (NME)
(Eteplirsen; Sarepta Therapeutics)
Class/route: First-in-class antisense oligonucleotide; intravenous infusion
Indication: For the treatment of Duchenne muscular dystrophy in patients with confirmed DMD mutation that is amenable to exon 51 skipping
Approval considerations: Accelerated approval, fast track, priority review, orphan drug
Approval date: September 19, 2016

Lartruvo (BLA)
(Olaratumab; Eli Lilly)
Class/route: Platelet-derived growth factor receptor alpha–blocking antibody; intravenous infusion
Indication: For the treatment, in combination with doxorubicin, of adults with soft-tissue sarcoma and a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery
Approval considerations: Accelerated approval, breakthrough therapy, fast track, priority review, orphan drug
Approval date: October 19, 2016

Netspot (NME)
(Kit for preparation of gallium Ga 68 dotatate injection; Gipharma)
Class/route: Radioactive diagnostic agent; intravenous infusion
Indication: For use with positron emission tomography for the localization of somatostatin receptor–positive neuroendocrine tumors in adults and in pediatric patients
Approval considerations: Priority review, orphan drug
Approval date: June 1, 2016

Nuplazid (NME)
(Pimavanserin; Acadia Pharmaceuticals)
Class/route: Atypical antipsychotic; oral
Indication: For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis
Approval considerations: Breakthrough therapy, priority review
Approval date: April 29, 2016

Ocaliva (NME)
(Obeticholic acid; Intercept Pharmaceuticals)
Class/route: First-in-class farnesoid X receptor agonist; oral
Indication: For the treatment, in combination with ursodeoxycholic acid, of primary biliary cholangitis in adults with an inadequate response to ursodeoxycholic acid, or as monotherapy in adults who are unable to tolerate ursodeoxycholic acid
Approval considerations: Accelerated approval, fast track, priority review, orphan drug
Approval date: May 27, 2016

Rubraca (NME)
(Rucaparib; Clovis Oncology)
Class/route: Poly ADP-ribose polymerase inhibitor; oral
Indication: For the treatment of patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer who received ≥2 chemotherapies; patients should be selected for therapy based on an FDA-approved companion diagnostic for rucaparib
Approval considerations: Accelerated approval, breakthrough therapy, priority review, orphan drug
Approval date: December 19, 2016

Spinraza (NME)
(Nusinersen; Biogen)
Class/route: First-in-class survival motor neuron-2-directed antisense oligonucleotide; intrathecal injection
Indication: For the treatment of adult and pediatric patients with spinal muscular atrophy
Approval considerations: Fast track, priority review, rare pediatric disease priority review voucher, orphan drug
Approval date: December 23, 2016

Taltz (BLA)
(Ixekizumab; Eli Lilly)
Class/route: Humanized IL-17A antagonist; subcutaneous injection
Indication: For the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Approval consideration: Patient medication guide
Approval date: March 22, 2016

Tecentriq (BLA)
(Atezolizumab; Genentech)
Class/route: PD-L1; intravenous infusion
Indications: For the treatment of patients with locally advanced or metastatic urothelial carcinoma with disease progression during or after platinum-containing chemotherapy, or with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; and for the treatment of patients with metastatic non–small-cell lung cancer whose disease progressed during or after platinum-containing chemotherapy. Patients with EGFR or ALK mutations should have disease progression with FDA-approved therapy for these aberrations before using atezolizumab
Approval considerations: Accelerated approval, breakthrough therapy, priority review
Approval dates: May 18, 2016 (bladder cancer); October 18, 2016 (lung cancer)

Venclexta (NME)
(Venetoclax; AbbVie/Genentech)
Class/route: First-in-class BCL-2 inhibitor; oral
Indication: For the treatment of patients with chronic lymphocytic leukemia with 17p deletion (as detected by an FDA-approved test) who have received at least 1 previous therapy
Approval considerations: Accelerated approval, breakthrough therapy, priority review, orphan drug
Approval date: April 11, 2016

Xiidra (NME)
(Lifitegrast; Shire)
Class/route: First-in-class lymphocyte function–associated antigen-1 antagonist; topical ophthalmic solution
Indication: For the treatment of the signs and symptoms of dry eye disease
Approval consideration: Priority review
Approval date: July 11, 2016

Zepatier (NME and new combination)
(Elbasvir and grazoprevir; Merck)
Classes/route: HCV NS5A inhibitor and HCV NS3/4A protease inhibitor; oral
Indication: For treatment of adults with chronic HCV infection genotype 1 or 4; should be administered with ribavirin in certain patient populations
Approval considerations: Breakthrough therapy, priority review
Approval date: January 28, 2016

Zinbryta (BLA)
(Daclizumab; Biogen/AbbVie)
Class/route: First-in-class IL-2 receptor blocking antibody; subcutaneous injection
Indication: For the treatment of adults with relapsing forms of multiple sclerosis. Because of its safety profile, Zinbryta should generally be reserved for patients who have had an inadequate response to ≥2 drugs indicated for the treatment of multiple sclerosis
Approval consideration: REMS program
Approval date: May 27, 2016

Zinplava (BLA)
(Bezlotoxumab; Merck)
Class/route: First-in-class human monoclonal antibody that binds to Clostridium difficile toxin B; intravenous injection
Indication: To reduce the recurrence of C difficile infection in patients aged ≥18 years who are receiving antibacterial drug treatment for C difficile infection and are at a high risk for infection recurrence
Approval considerations: Accelerated approval, breakthrough therapy, fast track, priority review
Approval date: October 21, 2016

BLA indicates biologic license application; GLP, glucagon-like peptide; HCV, hepatitis C virus; IL, interleukin; NME, new molecular entity; PD-L1, PD ligand 1; PDE, phosphodiesterase; REMS, Risk Evaluation and Mitigation Strategy.

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2. New Indications and New Combinations

Adynovate (new indication)
(Antihemophilic factor [recombinant], pegylated; Shire)
Class/route: Recombinant factor VIII; intravenous injection
New indication: For perioperative management of hemophilia A (congenital factor VIII deficiency) in children and adults
Existing indications: For on-demand treatment and control of bleeding episodes in children and adults with hemophilia A (congenital factor VIII deficiency); for routine prophylaxis to reduce the frequency of bleeding episodes
See also New Populations listing

Afinitor (new indication)
(Everolimus; Novartis)
Class/route: Serine-threonine kinase inhibitor; oral tablets
New indication: For treatment of adults with progressive neuroendocrine tumors of pancreatic origin and adults with progressive, well-differentiated, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable, locally advanced, or metastatic
Existing indications: For treatment of, in combination with exemestane after nonresponse to treatment with letrozole or anastrozole, postmenopausal women with advanced HR-positive, HER2-negative breast cancer; for adults with advanced renal-cell carcinoma after nonresponse to treatment with sunitinib or sorafenib; for adults with renal angiomyolipoma and tuberous sclerosis complex not requiring immediate surgery

Arzerra (new indications)
(Ofatumumab; Novartis)
Class/route: CD20-directed cytolytic monoclonal antibody; intravenous injection
New indications: For treatment of relapsed CLL in combination with fludarabine and cyclophosphamide; for extended treatment of recurrent or progressive CLL in patients with complete or partial response after at least 2 lines of therapy
Existing indications: For treatment of, in combination with chlorambucil, treatment-naïve patients with CLL for whom fludarabine-based therapy is inappropriate; for patients with CLL refractory to fludarabine and to alemtuzumab

Avastin (new indications)
(Bevacizumab; Genentech)
Class/route: VEGF inhibitor; intravenous infusion
New indications: For treatment, in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine chemotherapy, followed by bevacizumab alone, of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and for recurrent epithelial ovarian, fallopian, or primary peritoneal cancer that is platinum-sensitive, in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by bevacizumab as a single agent
Existing indications: For treatment, in combination with paclitaxel, with pegylated liposomal doxorubicin, or with topotecan, of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with chemotherapy, for treatment of patients with metastatic colorectal cancer; nonsquamous NSCLC; glioblastoma; metastatic renal-cell carcinoma; or cervical cancer
Approval consideration: Priority review

Bevespi Aerosphere (new combination)
(Glycopyrrolate and formoterol fumarate; AstraZeneca)
Classes/route: An anticholinergic and a long-acting beta2-adrenergic agonist; oral inhalation
Indication: For long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease

Blincyto (new indication)
(Blinatumomab; Amgen)
Class/route: Bispecific CD19-directed CD3 T-cell engager; intravenous injection
New indication: For treatment of pediatric patients with Ph-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia
Existing indication: For treatment of adults with Ph-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia
Approval considerations: Accelerated approval, REMS program

Botox (new indication)
(OnabotulinumtoxinA; Allergan)
Classes/routes: Acetylcholine release inhibitor and neuromuscular-blocking agent; intramuscular, intradetrusor, or intradermal injection
New indication: Treatment of spasticity in adults
Existing indications: For treatment of overactive bladder; urinary incontinence; cervical dystonia; severe axillary hyperhidrosis; strabismus; blepharospasm; for prophylaxis treatment of headaches in adults with chronic migraine

Byvalson (new combination)
(Nebivolol and valsartan; Allergan)
Classes/route: Beta adrenergic blocker and angiotensin II receptor blocker; oral tablets
Indication: For treatment of hypertension, to lower blood pressure

Cosentyx (new indications)
(Secukinumab; Novartis)
Class/route: Human IL-17A antagonist; subcutaneous injection
New indications: For treatment of adults with active psoriatic arthritis; for treatment of adults with active ankylosing spondylitis
Existing indication: For treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

Daklinza (new indication)
(Daclatasvir; Bristol-Myers Squibb)
Class/route: HCV NS5A inhibitor; oral tablets
New indication: For treatment of, with sofosbuvir and with or without ribavirin, chronic HCV infection genotype 1 or 3
Existing indication: For treatment of, with sofosbuvir and with or without ribavirin, chronic HCV infection genotype 3

Darzalex (new indication)
(Daratumumab; Janssen Biotech)
Class/route: CD38-directed cytolytic antibody; intravenous injection
New indication: For treatment, in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, of patients with multiple myeloma who have received at least 1 previous therapy
Existing indications: For use as monotherapy in patients with multiple myeloma who have received at least 3 previous lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or those who are double refractory to a proteasome inhibitor and an immunomodulatory agent
Approval consideration: Breakthrough therapy

Descovy (new combination)
(Emtricitabine and tenofovir alafenamide; Gilead Sciences)
Class/route: 2 nucleoside analog reverse transcriptase inhibitors; oral tablets
Indication: For treatment, in combination with other antiretroviral agents, of HIV-1 infection in patients aged ≥12 years

Dysport (new indication)
(AbobotulinumtoxinA; Ipsen Biopharm)
Classes/route: Acetylcholine release inhibitor and neuromuscular-blocking agent; intramuscular injection
New indication: For treatment of lower-limb spasticity in pediatric patients aged ≥2 years
Existing indications: For treatment of adults with cervical dystonia; for temporary improvement in the appearance of moderate-to-severe glabellar lines associated with procerus and corrugator muscle activity in patients aged <65 years; for treatment of upper-limb spasticity in adults

Enbrel (new indication)
(Etanercept; Amgen)
Class/route: TNF blocker; subcutaneous injection
New indication: For treatment of plaque psoriasis in patients aged ≥4 years
Existing indications: For treatment of patients with rheumatoid arthritis; for treatment of polyarticular JIA in patients aged ≥2 years; for treatment of psoriatic arthritis; for treatment of ankylosing spondylitis

Gadavist (new indication)
(Gadobutrol; Bayer HealthCare)
Class/route: Gadolinium-based contrast agent; intravenous injection
New indication: To evaluate known or suspected supra-aortic or renal artery disease in adults and in pediatric patients, including term neonates
Existing indications: To detect and visualize areas with disrupted blood–brain barrier and/or abnormal vascularity of the central nervous system in adults and pediatric patients (including term neonates); to assess the presence and extent of malignant breast disease

Gazyva (new indication)
(Obinutuzumab; Genentech)
Class/route: CD20-directed cytolytic antibody; intravenous injection
New indication: For treatment of, in combination with bendamustine followed by obinutuzumab monotherapy, patients with follicular lymphoma whose disease relapsed after, or who are refractory to, a rituximab-containing regimen
Existing indication: For treatment, in combination with chlorambucil, of patients with previously untreated CLL
Approval consideration: Priority review

Gilotrif (new indication)
(Afatinib; Boehringer Ingelheim)
Class/route: TKI; oral tablets
New indication: For treatment of patients with metastatic squamous NSCLC that has progressed after platinum-based chemotherapy
Existing indication: For first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test

Halaven (new indication)
(Eribulin mesylate; Eisai)
Class/route: Microtubule inhibitor; intravenous injection
New indication: For treatment of unresectable or metastatic liposarcoma in patients who have received an anthracycline-containing regimen
Existing indication: For treatment of metastatic breast cancer in patients who have received ≥2 chemotherapeutic regimens, including an anthracycline and a taxane in the adjuvant or metastatic setting
Approval considerations: Orphan drug, priority review

Harvoni (new indications)
(Ledipasvir and sofosbuvir; Gilead Sciences)
Classes/route: HCV NS5A inhibitor and HCV nucleotide analog NS5B polymerase inhibitor; oral tablets
New indications: For treatment, with or without ribavirin, of HCV infection genotype 1, 4, 5, or 6, including patients with chronic HCV infection genotype 1 or 4 who are liver transplant recipients without cirrhosis or with compensated cirrhosis; for patients with HCV genotype 1 infection with decompensated cirrhosis
Existing indications: For treatment of adults with chronic HCV infection genotype 1; for patients with genotype 4, 5, and 6 HCV infection; and in patients co-infected with HCV and HIV; for use with ribavirin for 12 weeks an alternate therapy to 24 weeks of monotherapy with Harvoni for patients with genotype 1 and cirrhosis who have received previous treatment

Hiberix (new indication)
(Haemophilus B conjugate vaccine; GlaxoSmithKline)
Class/route: Vaccine; intramuscular injection
New indication: For active immunization for prevention of invasive disease caused by Haemophilus influenzae type B in children aged 6 weeks through 4 years
Existing indication: As a booster dose in children aged 15 months to 4 years
See also New Populations listing

Humira (new indication)
(Adalimumab; AbbVie)
Class/route: TNF blocker; subcutaneous injection
New indication: For treatment of adults with noninfectious intermediate, posterior, and panuveitis uveitis
Existing indications: For treatment of rheumatoid arthritis; for treatment of JIA; psoriatic arthritis; ankylosing spondylitis; for treatment of adults and pediatric patients with Crohn’s disease; ulcerative colitis; plaque psoriasis; hidradenitis suppurativa

Ibrance (new indication)
(Palbociclib; Pfizer)
Class/route: CDK4 and CDK6 inhibitor; oral capsules
New indication: For treatment, in combination with fulvestrant, of women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression after endocrine therapy
Existing indication: For treatment of, in combination with letrozole as initial endocrine-based therapy in postmenopausal women, with HR-positive, HER2-negative advanced or metastatic breast cancer
Approval considerations: Accelerated approval, breakthrough therapy, priority review

Ilaris (new indications)
(Canakinumab; Novartis)
Class/route: IL-1beta monoclonal antibody; subcutaneous injection
New indications: First treatment approved for treatment of TNF receptor–associated periodic syndrome in adults and children; first treatment approved for hyperimmunoglobulin D syndrome/mevalonate kinase deficiency in adults and children; for familial Mediterranean fever in adults and children
Existing indications: For treatment of cryopyrin-associated periodic syndromes in adults and children aged ≥4 years, including familial cold autoinflammatory syndrome and Muckle-Wells syndrome; for treatment of active systemic JIA in patients aged ≥2 years

Imbruvica (new indications)
(Ibrutinib; Pharmacyclics, Janssen Biotech)
Class/route: Bruton’s TKI; oral capsules
New indications: For treatment of patients with CLL or SLL; for treatment of CLL or SLL in patients with 17p deletion (January 19, 2017: first nonchemotherapy approved for relapsed or refractory marginal zone lymphoma in patients requiring systemic therapy who had received at least 1 anti-CD20–based therapy)
Existing indications: For treatment of mantle-cell lymphoma in patients who have received at least 1 previous therapy; for treatment of Waldenström’s macroglobulinemia

Invokamet (new indication)
(Canagliflozin and metformin hydrochloride; Janssen Pharmaceuticals)
Classes/route: SGLT2 inhibitor and biguanide; oral tablets
New indication: For first-line treatment in adults with type 2 diabetes who are not already receiving treatment with canagliflozin and metformin
Existing indication: As an adjunct to diet and exercise, a fixed-dose combination of metformin and canagliflozin, to improve glycemic control in adults with type 2 diabetes who are not adequately controlled with metformin or canagliflozin alone
See also New Formulations listing

Jardiance (new indication)
(Empagliflozin; Boehringer Ingelheim)
Class/route: SGLT2 inhibitor; oral tablets
New indication: For reduction of cardiovascular death risk in adults with type 2 diabetes and established cardiovascular disease
Existing indication: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Keytruda (new indications)
(Pembrolizumab; Merck)
Class/route: PD-1–blocking antibody; intravenous injection
New indications: For treatment of metastatic NSCLC in patients whose tumors have high PD-L1 expression, as determined by an FDA-approved test, and no EGFR or ALK mutations and no previous systemic chemotherapy treatment; for treatment of metastatic NSCLC in patients whose tumors express PD-L1, as determined by an FDA-approved test, and disease progression during or after platinum-containing chemotherapy; for treatment of recurrent or metastatic head and neck squamous-cell carcinoma in patients with disease progression during or after platinum-containing chemotherapy
Existing indications: Unresectable or metastatic melanoma
Approval consideration: Accelerated approval

Kovanaze (new combination)
(Tetracaine HCl and oxymetazoline HCl; St. Renatus)
Classes/route: An ester local anesthetic and vasoconstrictor; nasal spray
Indication: For regional anesthesia when performing a restorative procedure on teeth 4-13 and A-J in adults and children who weigh ≥40 kg

Kyprolis (new indication)
(Carfilzomib; Amgen)
Class/route: Proteasome inhibitor; intravenous injection
New indication: For treatment of, in combination with dexamethasone or with lenalidomide plus dexamethasone, patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy
Existing indication: As monotherapy for treatment of relapsed or refractory multiple myeloma in patients who have received ≥1 lines of therapy

Lenvima (new indication)
(Lenvatinib; Eisai)
Class/route: Receptor TKI; oral capsules
New indication: For treatment, in combination with everolimus, of patients with advanced renal-cell carcinoma after 1 previous antiangiogenic therapy
Existing indication: For treatment, as monotherapy, of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer
Approval considerations: Priority review, breakthrough therapy

Odefsey (new combination)
(Emtricitabine, rilpivirine, and tenofovir alafenamide; Gilead Sciences)
Classes/route: HIV nucleoside analog reverse transcriptase inhibitors and a nonnucleoside reverse transcriptase inhibitor; oral tablets
Indications: For initial treatment of HIV-1 infection in patients aged ≥12 years who have not received antiretroviral treatment and who have RNA ≤100,000 copies/mL; to replace a stable antiretroviral regimen in patients who are virologically suppressed for at least 6 months with no history of treatment nonresponse and no known substitutions associated with resistance to the individual components of Odefsey
Approval consideration: Priority review

Opdivo (new indications)
(Nivolumab; Bristol-Myers Squibb)
Class/route: PD-1 blocking antibody; intravenous injection
New indications: For treatment, in combination with ipilimumab, of patients with BRAF V600 wild-type and BRAF V600 mutation–positive unresectable or metastatic melanoma; classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem-cell transplantation and posttransplant brentuximab vedotin; for treatment of recurrent or metastatic squamous-cell carcinoma of the head and neck, with disease progression during or after platinum-based therapy
Existing indications: For treatment of metastatic melanoma; metastatic NSCLC; renal-cell carcinoma
Approval consideration: Accelerated approval
See also New Dosage listing

Prevnar 13 (new indication)
(Pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 protein]; Wyeth Pharmaceuticals)
Class/route: Pneumococcal 13-valent conjugate vaccine; intramuscular injection
New indication: For active immunization for prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults aged ≥18 years
Existing indications: For active immunization for the prevention of invasive disease caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in children aged 6 weeks through 5 years; for active immunization for prevention of otitis media caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in children aged 6 weeks through 5 years; for active immunization for prevention of invasive disease caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in children aged 6 years through 17 years
See also New Populations listing

Soliqua (new combination)
(Insulin glargine and lixisenatide; Sanofi)
Classes/route: Long-acting human insulin analog and GLP-1 receptor agonist; subcutaneous injection
Indication: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes that is inadequately controlled with basal insulin or with lixisenatide
Approval consideration: Priority review

Stelara (new indication)
(Ustekinumab; Janssen Biotech)
Class/routes: Human IL-12 and IL-23 antagonist; sub­cutaneous or intravenous injection
New indication: For treatment of adults with moderately to severely active Crohn’s disease who did not respond to or were intolerant of treatment with ≥1 TNF blockers
Existing indications: For treatment of moderate-to-severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy; for treatment of active psoriatic arthritis, alone or in combination with methotrexate; for treatment of moderately to severely active Crohn’s disease in patients who did not respond to or are intolerant of immunomodulators or corticosteroids, but responded to a TNF blocker

Tarceva See New Populations listing

Tecentriq See NMEs and New BLAs listing

Troxyca ER (new combination)
(Oxycodone hydrochloride and naltrexone hydrochloride; Pfizer)
Classes/route: Opioid agonist and opioid antagonist; extended-release, abuse-deterrent oral capsules, CII
Indication: For management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
Approval consideration: REMS program

Vibativ (new indication)
(Telavancin; Theravance Biopharma)
Class/route: Lipoglycopeptide antibacterial drug; intravenous injection
New indication: For treatment of adults with complicated skin and skin structure infections caused by susceptible isolates of Gram-positive bacteria, including methicillin-susceptible and methicillin-resistant strains of Staphylococcus aureus
Existing indications: For treatment of complicated skin and skin structure infections; for treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible isolates of S aureus

Xalkori (new indication)
(Crizotinib; Pfizer)
Class/route: Receptor TKI; oral capsules
New indication: For treatment of metastatic NSCLC in patients with ROS1 mutation
Existing indication: For treatment of metastatic NSCLC in patients with ALK mutation, as detected by an FDA-approved test

Xultophy (new combination)
(Insulin degludec and liraglutide; Novo Nordisk)
Classes/route: Long-acting human insulin analog and GLP-1 receptor agonist; subcutaneous injection
Indication: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes that is inadequately controlled with basal insulin or with liraglutide alone
Approval consideration: REMS program

Yosprala (new combination)
(Aspirin and omeprazole; Aralez Pharmaceuticals)
Classes/route: Antiplatelet agent and proton pump inhibitor; delayed-release oral tablets
Indication: For secondary prevention of cardiovascular and cerebrovascular events in patients who require aspirin and are at risk for aspirin-associated gastric ulcers

ALK indicates anaplastic lymphoma kinase; BLA, biologic license application; CDK, cyclin-dependent kinase; CLL, chronic lymphocytic leukemia; EGFR, epidermal growth factor receptor; FDA, US Food and Drug Administration; GLP-1, glucagon-like peptide-1; HCV, hepatitis C virus; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IL, interleukin; JIA, juvenile idiopathic arthritis; NME, new molecular entity; NSCLC, non–small-cell lung cancer; PD, programmed-cell death; PD-L1, PD ligand 1; Ph, Philadelphia chromosome; REMS, Risk Evaluation and Mitigation Strategy; SGLT2, sodium-glucose cotransporter 2; SLL, small lymphocytic lymphoma; TKI, tyrosine kinase inhibitor; TNF, tumor necrosis factor; VEGF, vascular endothelial growth factor.

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3. New Dosages, New Dosage Forms, New Formulations, New Delivery Systems, and New Patient Populations

Aczone Gel (new dosage)
(Dapsone; Allergan)
Class/route: Sulfone; topical gel
New dosage: 7.5% gel once daily
Existing dosage: 5% gel twice daily
Indication: For topical treatment of acne vulgaris in patients aged ≥12 years

Adynovate (new patient population)
(Antihemophilic factor, PEGylated; Shire)
Class/route: Recombinant factor VIII; intravenous injection
New patient population: Children aged <12 years
Existing patient population: Children and adults aged ≥12 years
Indications: For perioperative management of hemophilia A (congenital factor VIII deficiency) in children and adults; for children and adults with hemophilia A (congenital factor VIII deficiency) for the on-demand treatment and control of bleeding episodes; for routine prophylaxis to reduce the frequency of bleeding episodes
See also New Indications listing

Adzenys XR-ODT (new formulation)
(Amphetamine extended-release; Neos Therapeutics)
Class/route: CNS stimulant; oral tablets
New formulation: First extended-release orally dis­integrating tablets
Indication: For treatment of attention-deficit/hyper­activity disorder in patients aged ≥6 years

Afluria Quadrivalent (new formulation)
(Influenza vaccine; Seqirus)
Class/route: Influenza vaccine; intramuscular injection
New formulation: Single-dose, preservative-free, prefilled syringes
Existing formulation: Prefilled syringes and multidose vials
Indication: For active immunization of patients ≥18 years against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine

Ameluz (new dosage form)
(Aminolevulinic acid hydrochloride; Biofrontera AG)
Class/route: Porphyrin precursor; topical gel
New dosage form: 10% gel
Existing dosage form: 20% solution for topical use
Indication: For the lesion-directed and field-directed treatment, in combination with photodynamic therapy using BF-RhodoLED lamp, of mild-to-moderate actinic keratoses on the face and scalp

Belviq XR (new formulation)
(Lorcaserin hydrochloride; Eisai)
Class/route: Serotonin 2C receptor agonist; oral tablets
New formulation: 20-mg film-coated extended-release tablets
Existing formulation: 10-mg film-coated tablets
Indication: An adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of ≥30 kg/m2 (obese) or ≥27 kg/m2 in the presence of at least 1 weight-related comorbid condition

BromSite (new formulation)
(Bromfenac ophthalmic solution; Sun Pharma)
Class/route: NSAID; topical ophthalmic
New formulation: Polymer-based preparation containing 0.075% formulation of bromfenac ophthalmic solution
Indication: For treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery

Cabometyx (new dosage form)
(Cabozantinib; Exelixis)
Class/route: Kinase inhibitor; Oral tablets
New dosage form: 20-mg, 40-mg, and 60-mg tablets
Existing dosage form: oral capsules
Indication: For treatment of advanced renal-cell carcinoma in patients who received previous anti­angiogenic therapy

Carnexiv (new dosage form)
(Carbamazepine; Lundbeck)
Class/route: Anticonvulsant; intravenous infusion
New dosage form: 200-mg/20-mL single-dose vial
Existing dosage forms: Chewable tablets, extended-release capsules, extended-release tablets, immediate-release tablets, oral suspension
Indications: Replacement therapy for oral carbamazepine formulations when oral administration is temporarily not feasible, in adults with partial seizures and complex symptomatology; generalized tonic-clonic seizures; or mixed seizure patterns or other partial or generalized seizures

Cetylev (new dosage form)
(Acetylcysteine; Arbor Pharmaceuticals)
Class/route: Mucolytic agent; effervescent tablets for oral solution
New dosage form: 500-mg and 2.5-mg effervescent tablets for oral solution
Existing dosage forms: Inhalation solution; intravenous solution; oral capsule; oral tablet; compounding powder
Indication: To prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion

Dalvance (new dosage)
(Dalbavancin; Durata Therapeutics/Allergan)
Class/route: Antibacterial; intravenous infusion
New dosage: 1500-mg intravenous infusion in a single dose
Existing dosage: 1000-mg intravenous infusion followed by 500 mg 1 week later
Indication: For acute bacterial skin and skin structure infections caused by designated susceptible strains of Gram-positive microorganisms

Dexilant SoluTab (new dosage form)
(Dexlansoprazole; Takeda)
Class/route: Proton pump inhibitor; oral tablets
New dosage form: 30-mg delayed-release, orally disintegrating tablets
Existing dosage form: 30-mg and 60-mg delayed-release capsules
Indication: For patients aged ≥12 years for healing of all grades of erosive esophagitis; maintenance of healed erosive esophagitis and relief of heartburn; treatment of symptomatic, nonerosive gastroesophageal reflux disease

Emverm (new dosage)
(Mebendazole; Impax Laboratories)
Class/route: Synthetic, broad-spectrum anthelmintic; oral tablets
New dosage: 100-mg chewable tablets
Existing dosage: 500-mg chewable tablets
Indication: For treatment of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale, and Necator americanus in a single infection or mixed infections

Evomela (new formulation)
(Melphalan; Spectrum Pharmaceuticals)
Class/route: Bischloroethylamine alkylating agent; intravenous infusion
New formulation: Melphalan that is free of propylene glycol, with Captisol technology to improve the solubility and stability of melphalan
Existing formulation: Melphalan with propylene glycol as a cosolvent
Indications: For high-dose conditioning treatment before hematopoietic progenitor-cell transplantation in patients with multiple myeloma; for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate

Flublok Quadrivalent (new formulation)
(Influenza vaccine; Protein Sciences)
Class/route: Recombinant, protein-based vaccine; intramuscular injection
New formulation: First quadrivalent formulation of Flublok containing 4 strains of influenza, including A/California/7/2009 (H1N1)-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, B/Brisbane/60/2008-like virus, and B/Phuket/3073/2013-like virus
Existing formulation: Flublok Trivalent formulation containing 3 strains of influenza, including A/California/7/2009 (H1N1)-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus
Indication: For active immunization of patients aged ≥18 years against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine

FluLaval Quadrivalent (new patient population)
(Influenza vaccine; GlaxoSmithKline)
Class/route: Vaccine; suspension for intramuscular injection
New patient population: Patients aged ≥6 months
Existing patient population: Patients aged ≥3 years
Indication: For active immunization of patients aged ≥6 months for prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine

Fycompa (new dosage form)
(Perampanel; Eisai)
Class/route: Noncompetitive AMPA glutamate receptor antagonist; oral suspension
New dosage form: 0.5-mg/mL oral suspension
Existing dosage form: 2-mg, 4-mg, 6-mg, 8-mg, 10-mg, 12-mg oral tablets
Indications: Adjunctive therapy for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged ≥12 years; for primary generalized tonic-clonic seizures in patients with epilepsy aged ≥12 years

GoNitro (new dosage form)
(Nitroglycerin; Espero Pharmaceuticals)
Class/route: Nitrate vasodilator; sublingual powder
New dosage form: 400-mcg sublingual powder per packet
Existing dosage forms: Transdermal patch; extended release; sublingual tablet; intravenous solution; buccal tablet; sublingual spray; transdermal ointment; oral capsule; rectal ointment
Indication: For acute relief of an attack or prophylaxis of angina pectoris because of coronary artery disease

Hiberix (new patient population)
(Haemophilus B conjugate vaccine; GlaxoSmithKline)
Class/route: Vaccine; intramuscular injection
New patient population: Children aged 6 weeks through 4 years
Previous patient population: Children aged 15 months through 4 years (administered as a booster dose)
Indication: For active immunization to prevent invasive disease caused by Haemophilus influenzae type B in children aged 6 weeks through 4 years
See also New Indications listing

Humulin R U-500 (new dosage form)
(Insulin human injection; Eli Lilly)
Class/route: Human insulin; subcutaneous injection
New dosage form: Prefilled pen containing 1500 units of insulin
Existing dosage form: Vial containing 10,000 units of insulin
Indication: To improve glycemic control in adults and children with diabetes mellitus requiring >200 units of insulin daily

Intrarosa (new delivery system)
(Prasterone; Endoceutics)
Class/route: Steroid; vaginal insert
New delivery system: First FDA-approved drug delivery system containing the active ingredient prasterone (dehydroepiandrosterone)
Indication: Once-daily vaginal insertion for treatment of moderate-to-severe dyspareunia resulting from menopause

Invokamet XR (new dosage form)
(Canagliflozin and metformin hydrochloride extended-release; Janssen Pharmaceuticals)
Classes/route: SGLT2 and a biguanide; oral tablets
New dosage form: Extended-release, once-daily, fixed-dose combination of an SGLT2 and a biguanide
Existing dosage form: Twice-daily, fixed-dose combination of an SGLT2 and an extended-release biguanide
Indication: For first-line treatment as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with canagliflozin plus metformin is appropriate
See also New Indications listing

Jentadueto XR (new formulation)
(Linagliptin and metformin hydrochloride extended-release; Boehringer Ingelheim/Eli Lilly)
Classes/route: DPP-4 inhibitor and biguanide; oral tablets
New formulation: Extended-release, once-daily combination of a DPP-4 inhibitor and an extended-release biguanide
Existing formulation: Twice-daily combination of a DPP-4 inhibitor and a biguanide
Indication: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate

Kyleena (new delivery system)
(Levonorgestrel-releasing intrauterine system; Bayer HealthCare)
Class/route: Progestin; intrauterine system
New delivery system: Progestin-releasing intrauterine system consisting of a T-shaped polyethylene frame with a steroid reservoir containing 19.5-mg levonorgestrel
Indication: Contraception for prevention of pregnancy for up to 5 years

Lomaira (new formulation)
(Phentermine hydrochloride; KVK Tech)
Class/route: Sympathomimetic amine anorectic; oral tablets
New formulation: Low-dose tablet containing 8-mg phentermine hydrochloride for use up to 3 times daily
Existing formulation: 15-mg, 30-mg, and 37.5-mg oral capsules
Indication: Adjunct in a weight-reduction regimen of exercise, behavioral modification, and caloric restriction in the management of exogenous obesity in patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 and other risk factors (eg, controlled hypertension, diabetes, and hyperlipidemia)

Lucentis (new dosage form)
(Ranibizumab; Genentech)
Class/route: VEGF inhibitor; intravitreal injection
New dosage form: Prefilled syringe to provide single-use 0.05 mL for intravitreal injections
Existing dosage form: Glass vial to provide single-use 0.05 mL for intravitreal injections
Indications: For treatment of neovascular (wet) age-related macular degeneration; macular edema after retinal vein occlusion; diabetic macular edema; diabetic retinopathy in patients with diabetic macular edema; myopic choroidal neovascularization

Onzetra Xsail (new dosage form)
(Sumatriptan nasal powder; Avanir Pharmaceuticals)
Class/route: Serotonin 5-HT1B/1D receptor agonist; intranasal
New dosage form: Disposable nosepiece containing a capsule with 11-mg sumatriptan base and a reusable delivery device
Existing dosage forms: Oral tablet; subcutaneous solution; subcutaneous kit; nasal spray; transdermal patch; extended release
Indication: For treatment of acute migraine, with or without aura, in adults

Opdivo (new dosage)
(Nivolumab; Bristol-Myers Squibb)
Class/route: PD-1–blocking antibody; intravenous
New dosage: 240 mg intravenously every 2 weeks until disease progression or intolerable toxicity
Existing dosage: Single-dose regimen of 3 mg/kg intra­venously every 2 weeks
Indications: For unresectable or metastatic melanoma; metastatic NSCLC; advanced renal-cell carcinoma; Hodgkin lymphoma
See also New Indications listing

Orkambi (new patient population)
(Lumacaftor and ivacaftor; Vertex)
Class/route: Combination of lumacaftor and ivacaftor; oral
New patient population: Patients aged 6 years through 11 years
Existing patient population: Patients aged ≥12 years
Indication: For treatment of cystic fibrosis in patients aged ≥6 years who are homozygous for the F508del mutation in the CFTR gene, as confirmed by FDA-approved test to detect the F508del mutation on both alleles of the CFTR gene

Otovel (new formulation)
(Ciprofloxacin and fluocinolone acetonide; Arbor Pharmaceuticals)
Class/route: Fluoroquinolone antibacterial and a corticosteroid; otic solution
New formulation: Combination of ciprofloxacin 0.3% and fluocinolone acetonide 0.025% for otic administration only
Indication: For treatment of acute otitis media with tympanostomy tubes in pediatric patients (aged ≥6 months) because of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, or Pseudomonas aeruginosa

Prevnar 13 (new patient population)
(Pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 protein]; Wyeth Pharmaceuticals)
Class/route: Pneumococcal 13-valent conjugate vaccine; intramuscular injection
New patient population: Adults aged ≥18 years for active immunization for prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
Existing populations: In children aged 6 weeks through 5 years for active immunization for the prevention of invasive disease caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; active immunization for the prevention of otitis media caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F; in children aged 6 years through 17 years for active immunization for prevention of invasive disease caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
See also New Indications listing

Prezista (new patient population)
(Darunavir; Janssen Pharmaceuticals)
Class/route: HIV-1 protease inhibitor; oral
New patient population: Pregnant women with HIV
Existing patient population: Children aged ≥3 years and adults with HIV
Indication: For treatment of HIV-1 infection in patients aged ≥3 years; must be coadministered with ritonavir and with other antiretroviral agents

ProAir RespiClick (new patient population)
(Albuterol sulfate; Teva Respiratory)
Class/route: Beta2-adrenergic agonist; oral inhalation
New patient population: Patients aged ≥4 years
Previous patient population: Patients aged ≥12 years
Indications: For treatment or prevention of bronchospasm in patients aged ≥4 years with reversible obstructive airway disease; prevention of exercise-induced bronchospasm in patients aged ≥4 years

Probuphine (new dosage form)
(Buprenorphine; Braeburn Pharmaceuticals)
Class/route: Partial opioid agonist; subdermal implant
New dosage form: Implant containing 74.2 mg of buprenorphine
Indication: For maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability with low-to-moderate doses of a transmucosal buprenorphine-containing drug

Qbrelis (new dosage form)
(Lisinopril; Silvergate Pharmaceuticals)
Class/route: ACE inhibitor; oral solution
New dosage form: 1-mg/mL oral solution
Existing dosage form: 2.5-mg, 5-mg, 10-mg, 20-mg, 30-mg, 40-mg tablets
Indications: For treatment of hypertension in adults and pediatric patients ≥6 years; adjunct therapy for heart failure; treatment of acute myocardial infarction

Rayaldee (new formulation)
(Calcifediol; OPKO Pharmaceuticals)
Class/route: Vitamin D3 analog; oral capsules
New formulation: 30-mcg extended-release capsules
Indication: For treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels <30 ng/mL

Relistor (new dosage form)
(Methylnaltrexone bromide; Salix Pharmaceuticals)
Class/route: Opioid antagonist; oral tablets
New dosage form: 150-mg tablets for oral use
Existing dosage forms: 12-mg/0.6-mL solution in single-use vials for subcutaneous injection; 8-mg/0.4-mL solution and 12-mg/0.6-mL solution in prefilled syringes for subcutaneous injection
Indication: For treatment of opioid-induced constipation in adults with chronic noncancer pain

Repatha (new delivery system)
(Evolocumab; Amgen)
Class/route: PCSK9 inhibitor antibody; subcutaneous injection
New delivery system: First single-dose (420-mg) monthly injection with the Pushtronex system, an on-body infusor with a prefilled cartridge
Existing delivery system: Single-use prefilled autoinjector or single-use prefilled syringe
Indications: Adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic CVD who require additional LDL-C lowering; adjunct to diet and other LDL-lowering therapies in patients with homozygous familial hypercholesterolemia who require additional lowering of LDL-C

Selzentry (new dosage form)
(Maraviroc; ViiV Healthcare)
Class/route: CCR5 coreceptor antagonist; oral solution
New patient population: Patients aged ≥2 years
Existing patient population: Adults
New dosage forms: 25-mg, 75-mg tablets; 20-mg/mL oral solution
Existing dosage form: 150-mg, 300-mg tablets
Indication: For treatment of only CCR5-tropic HIV-1 infection in patients aged ≥2 years and weighing at least 10 kg

Selzentry (new patient population)
(Maraviroc; ViiV Healthcare)
Class/route: CCR5 coreceptor antagonist; oral solution
New patient population: Patients aged ≥2 years
Previous patient population: Adults
Indication: For treatment of only CCR5-tropic HIV-1 infection in patients aged ≥2 years and weighing at least 10 kg

Sernivo Spray (new dosage form)
(Betamethasone dipropionate; Promius Pharma)
Class/route: Corticosteroid; topical spray
New dosage form: .05% spray
Existing dosage forms: Topical cream, lotion, ointment, gel, foam
Indication: For treatment of mild-to-moderate plaque psoriasis in patients aged ≥18 years

Sustol extended-release (new formulation)
(Granisetron; Heron Therapeutics)
Class/route: Serotonin-3 receptor antagonist; subcutaneous injection
New formulation: Extended-release injection using a polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days
Indication: For use in adults, in combination with other antiemetics, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination chemotherapy regimens

Syndros (new dosage form)
(Dronabinol; Insys Therapeutics)
Class/route: Cannabinoid; oral solution
New dosage form: 5-mg/mL oral solution
Existing dosage form: 2.5-mg, 5-mg, 10-mg capsules
Indications: For treatment of anorexia associated with weight loss in patients with AIDS; for treatment of chemotherapy-induced nausea and vomiting in patients with cancer who had not responded adequately to conventional antiemetic treatments

Synjardy (new patient population)
(Empagliflozin and metformin hydrochloride; Boehringer Ingelheim/Eli Lilly)
Class/route: SGLT2 inhibitor and a biguanide; oral tablets
New patient population: Treatment-naïve adults with type 2 diabetes
Existing patient population: Patients who received treatment for type 2 diabetes
Indication: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with empagliflozin and metformin hydrochloride is appropriate

Synjardy XR (new formulation)
(Empagliflozin and metformin hydrochloride; Boehringer Ingelheim/Eli Lilly)
Class/route: SGLT2 inhibitor and a biguanide; oral tablets
New formulation: Once-daily 25-mg empagliflozin/2000-mg metformin hydrochloride extended-release tablets
Existing formulation: Twice-daily 5-mg empagliflozin/1000-mg metformin hydrochloride tablets; 10-mg empagliflozin/1000-mg metformin hydrochloride tablets; 12.5-mg empagliflozin/1000-mg metformin hydrochloride tablets
Indication: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with empagliflozin and metformin hydrochloride is appropriate

Tarceva (new patient population)
(Erlotinib; OSI Pharmaceuticals)
Class/route: TKI; oral tablets
New patient population: Patients with metastatic NSCLC and EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test, that is progressing after at least 1 previous chemotherapy regimen
Existing patient population: Patients with locally advanced, unresectable, or metastatic pancreatic cancer
Indications: For treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 substitution mutations; for first-line treatment, in combination with gemcitabine, of locally advanced, unresectable or metastatic pancreatic cancer

Teflaro (new patient population)
(Ceftaroline fosamil; Allergan)
Class/route: Cephalosporin antibacterial; intravenous
New patient population: Pediatric patients aged ≥2 months to <18 years
Existing patient population: Adults aged ≥18 years
Indication: For treatment of acute bacterial skin and skin structure infections; for the treatment of community-acquired bacterial pneumonia

Tresiba (new patient population)
(Insulin degludec; Novo Nordisk)
Class/route: Long-acting human insulin analog; subcutaneous injection
New patient population: Patients aged ≥1 years
Existing patient population: Adults aged ≥18 years
Indication: To improve glycemic control in patients aged ≥1 years with diabetes mellitus

Veltassa (new dosage)
(Patiromer; Relypsa)
Class/route: Potassium binder; oral
New dosage: To be taken at least 3 hours before or 3 hours after other oral medications; the box warning regarding drug interactions has been removed
Indication: For treatment of hyperkalemia

Vemlidy (new formulation)
(Tenofovir alafenamide; Gilead Sciences)
Class/route: Hepatitis B virus nucleoside analog reverse transcriptase inhibitor; oral tablets
New formulation: 25-mg tablets (a novel, targeted pro­drug of tenofovir)
Indication: For treatment of chronic hepatitis B virus infection in adults with compensated liver disease

Vermox (new dosage)
(Mebendazole; Janssen Pharmaceuticals)
Class/route: Anthelmintic; oral tablets
New dosage: 500-mg chewable tablets
Existing dosage: 100-mg chewable tablets
Indication: For treatment of patients aged ≥1 years with gastrointestinal infections caused by Ascaris lumbricoides or Trichuris trichiura

Viekira XR (new dosage form)
(Dasabuvir, ombitasvir, paritaprevir, and ritonavir; AbbVie)
Class/route: HCV nonnucleoside NS5B palm polymerase inhibitor, HCV NS5A inhibitor, HCV NS3/4A protease inhibitor, and CYP3A inhibitor; oral tablets
New dosage form: Extended-release tablets
Existing dosage form: Tablets
Indications: For treatment of adults with chronic HCV infection genotype 1b, without cirrhosis or with compensated cirrhosis; for patients with HCV infection genotype 1a, without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin

Xeljanz XR (new formulation)
(Tofacitinib; Pfizer)
Class/route: Janus kinase inhibitor; oral tablets
New formulation: Once-daily extended-release 11-mg tablets
Existing formulation: Twice-daily 5-mg tablets
Indication: For treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate

Xolair (new patient population)
(Omalizumab; Novartis/Genentech)
Class/route: Anti-immunoglobulin E antibody; sub­cutaneous injection
New patient population: Patients aged ≥6 years
Existing patient population: Patients aged ≥12 years
Indications: For treatment of chronic idiopathic urticaria in adults and adolescents aged ≥12 years who remain symptomatic despite H1 antihistamine treatment; for moderate-to-severe persistent asthma in patients aged ≥6 years with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids

Xtampza ER (new formulation)
(Oxycodone; Collegium Pharmaceutical)
Class/route: Opioid agonist; oral capsules
New formulation: Abuse-deterrent, extended-release, twice-daily oral capsules
Indication: For management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate
Approval consideration: REMS program

Zembrace SymTouch (new formulation)
(Sumatriptan succinate; Promius Pharma)
Class/route: Serotonin 5-HT1B/1D receptor agonist; subcutaneous injection
New formulation: 3-mg prefilled, ready-to use, single-dose disposable autoinjector
Indication: For treatment of acute migraine, with or without aura, in adults

ACE indicates angiotensin-converting enzyme; CNS, central nervous system; CVD, cardiovascular disease; CY, cytochrome; DPP-4, dipeptidyl peptidase-4; EGFR, epidermal growth factor receptor; FDA, US Food and Drug Administration; 5-HT, 5-hydroxytryptamine; HCV, hepatitis C virus; LDL, low-density lipoprotein; LDL-C, low-density lipoprotein cholesterol; NSAID, nonsteroidal anti-inflammatory drug; NSCLC, non–small-cell lung cancer; PCSK9, proprotein convertase subtilisin/kexin type 9; PD-1, programmed-cell death 1; REMS, Risk Evaluation and Mitigation Strategy; SGLT2, sodium-glucose cotransporter 2; TKI, tyrosine kinase inhibitor; VEGF, vascular endothelial growth factor.

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4. New Biosimilars, New Blood Products, and New Vaccines

Afstyla (new blood product)
(Antihemophilic factor [recombinant], single chain; CSL Behring)
Class/route: Recombinant, antihemophilic factor; intravenous infusion
Indications: For treatment of patients with hemophilia A for on-demand treatment and controlling of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and perioperative management of bleeding

Amjevita (new biosimilar)
(Adalimumab-atto; Amgen)
Class/route: TNF blocker; subcutaneous injection
New biosimilar: Biosimilar to reference drug Humira (adalimumab)
Indications: For treatment of patients with moderately to severely active rheumatoid arthritis, moderately to severely active juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis (an arthritis that affects the spine), moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, or moderate to chronic severe plaque psoriasis

Cuvitru (new blood product)
(Immune globulin subcutaneous; Baxalta US)
Class/route: Immune globulin subcutaneous (human); subcutaneous infusion
Indication: As replacement therapy for primary humoral immunodeficiency in adult and pediatric patients aged ≥2 years

Erelzi (new biosimilar)
(Etanercept-szzs; Sandoz)
Class/route: TNF blocker; subcutaneous injection
New biosimilar: Biosimilar to reference drug Enbrel (etanercept)
Indications: For treatment of patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in patients aged ≥2 years, psoriatic arthritis, ankylosing spondylitis, or plaque psoriasis

Idelvion (new blood product)
(Coagulation factor IX, albumin fusion protein; CSL Behring)
Class/route: Recombinant blood coagulation factor IX; intravenous infusion
Indications: For children and adults with hemophilia B (congenital factor IX deficiency) for on-demand control and prevention of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes

Inflectra (new biosimilar)
(Infliximab-dyyb; Celltrion)
Class/route: TNF blocker; intravenous infusion
New biosimilar: Biosimilar to reference drug Remicade (infliximab)
Indications: For treatment of patients with Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis in combination with metho­trexate, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis

Kovaltry (new blood product)
(Antihemophilic factor; Bayer HealthCare)
Class/route: Recombinant antihemophilic factor VIII concentrate; intravenous infusion
Indications: For children and adults with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes

Vaxchora (new vaccine)
(Cholera vaccine, live, oral; PaxVax)
Class/route: Vaccine; oral suspension
Indication: First anticholera vaccine for active immunization against disease caused by Vibrio cholerae serogroup O1. Approved for adults aged 18 through 64 years traveling to cholera-affected areas

TNF indicates tumor necrosis factor.

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