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FDA Approvals of Brand-Name Prescription Drugs in 2012

April 2013 Vol 6 No 3 Payers’ Guide to New FDA Approvals - FDA Approvals, Drug Updates, Payers' Guide
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I. New Pharmaceuticals, NMEs, Biologics

Amyvid (NME)
(Florbetapir F18; Avid Radiopharmaceuticals)
Class/route: Diagnostic radiopharmaceutical; intravenous solution
Indication: To estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for positron emission tomography imaging of the brain for Alzheimer’s disease and other causes of cognitive decline
Approval consideration: Priority review

Aubagio (NME)
(Teriflunomide; Genzyme)
Class/route: Pyrimidine synthesis inhibitor; oral
Indication: Treatment of patients with relapsing forms
of multiple sclerosis

Belviq (NME)
(Lorcaserin hydrochloride; Eisai)
Class/route: Serotonin 2C receptor agonist; oral
Indication: For chronic weight management in adults with an initial body mass index of ≥30 kg/m2 (obese) or ≥27 kg/m2 (overweight) in the presence of at least 1 weight-related comorbid condition, an adjunct to a reduced-calorie diet and increased physical activity

Bosulif (NME)
(Bosutinib monohydrate; Pfizer)
Class/route: Kinase inhibitor; oral
Indication: Treatment of adult patients with chronic-, accelerated-, or blast-phase Ph-chromosome–positive chronic myelogenous leukemia with resistance to or intolerance of previous therapy
Approval consideration: Orphan drug

Choline C 11 (NME)
(Mayo Clinic PET Radiochemistry Facility)
Class/route: Radiopharmaceutical; intravenous
Indication: For use in positron emission tomography imaging of patients with suspected prostate cancer recurrence and noninformative bone scintigraphy, computerized tomography, or magnetic resonance imaging
Approval consideration: Priority review

Cometriq (NME)
(Cabozantinib; Exelixis)
Class/route: Kinase inhibitor; oral
Indication: Treatment of patients with progressive, metastatic medullary thyroid cancer
Approval considerations: Priority review, orphan drug

Elelyso (NME)
(Taliglucerase alfa; Pfizer)
Class/route: Hydrolytic lysosomal glucocerebroside–specific enzyme; intravenous solution
Indication: For long-term enzyme replacement therapy for adults with a confirmed diagnosis of type 1 Gaucher disease
Approval consideration: Orphan drug

Eliquis (NME)
(Apixaban; Bristol-Myers Squibb)
Class/route: Factor Xa inhibitor anticoagulant; oral
Indication: To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
Approval considerations: Priority review, REMS

Erivedge (NME)
(Vismodegib; Genentech)
Class/route: Hedgehog pathway inhibitor; oral
Indication: Treatment of adults with metastatic basal- cell carcinoma, or with locally advanced basal-cell carcinoma that has recurred after surgery, or who are not candidates for surgery and are not candidates for radiation
Approval consideration: Priority review

Fulyzaq (NME)
(Crofelemer; Salix Pharmaceuticals)
Class/route: Antidiarrheal; oral
Indication: For the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS who are receiving antiretroviral therapy
Approval consideration: Priority review

Fycompa (NME)
(Perampanel; Eisai)
Class/route: Noncompetitive AMPA glutamate receptor antagonist; oral
Indication: Adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged ≥12 years

Gattex (NME)
(Teduglutide recombinant; NPS Pharmaceuticals)
Class/route: Glucagon-like peptide-2 analog;
subcutaneous injection
Indication: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Approval considerations: Orphan drug, REMS

Gintuit (BLA)
(Allogeneic cultured keratinocytes and fibroblasts in bovine collagen; Organogenesis)
Class/route: Allogeneic cellularized scaffold product; topical
Indication: For application to vascular wound beds in the treatment of mucogingival conditions in adults

HPC, Cord Blood (BLA)
(ClinImmune Labs)
Class/route: Allogeneic cord blood hematopoietic progenitor cell therapy; intravenous Indication: Use in unrelated donor hematopoietic progenitor cell transplantation in patients with certain blood disorders

Iclusig (NME)
(Ponatinib hydrochloride; Ariad Pharmaceuticals)
Class/route: Kinase inhibitor; oral
Indication: Treatment of adult patients with chronic-, accelerated-, or blast-phase chronic myelogenous leukemia that is resistant or intolerant to previous TKI therapy or Ph-positive acute lymphoblastic leukemia that is resistant or intolerant to previous TKI therapy
Approval considerations: Priority review, orphan drug

Inlyta (NME)
(Axitinib; Pfizer)
Class/route: Kinase inhibitor; oral
Indication: Treatment of advanced renal-cell carcinoma after failure of 1 prior systemic therapy

Jetrea (BLA)
(Ocriplasmin; ThromboGenics)
Class/route: Proteolytic enzyme; intravitreal injection
Indication: Treatment of symptomatic vitreomacular adhesion
Approval consideration: Priority review

Juxtapid (NME)
(Lomitapide mesylate; Aegerion Pharmaceuticals)
Class/route: Microsomal triglyceride transfer protein inhibitor; oral
Indication: An adjunct to a low-fat diet and other lipid-­lowering treatments, including low-density lipoprotein apheresis where available, to reduce low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and non–high-density lipoprotein cholesterol in patients with homozygous familial hypercholesterolemia
Approval considerations: Orphan drug, REMS

Kalydeco (NME)
(Ivacaftor; Vertex Pharmaceuticals)
Class/route: Cystic fibrosis transmembrane conductive regulator potentiator; oral
Indication: Treatment of a rare form of cystic fibrosis in patients aged ≥6 years who have a G551D mutation in the CFTR gene
Approval considerations: Priority review, orphan drug

Korlym (NME)
(Mifepristone; Corcept Therapeutics)
Class/route: Cortisol receptor blocker; oral
Indication: To control hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed or are not candidates for surgery

Kyprolis (NME)
(Carfilzomib; Onyx Pharmaceuticals)
Class/route: Proteasome inhibitor; intravenous
Indication: Treatment of patients with multiple
myeloma who have received at least 2 previous therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy
Approval consideration: Orphan drug

Linzess (NME)
(Linclotide; Forest Laboratories)
Class/route: Guanylate cyclase-C agonist; oral
Indication: Treatment of adult patients with irritable bowel syndrome with constipation and chronic idiopathic constipation

Marqibo (NME)
(Vincristine sulfate liposome; Talon Therapeutics)
Class/route: Vinca alkaloid; intravenous
Indication: Treatment of adult patients with Ph-negative acute lymphoblastic leukemia that has relapsed ≥2 times or whose disease has progressed after ≥2 antileukemia therapies
Approval consideration: Orphan drug

MenHibrix (BLA)
(GlaxoSmithKline Biologicals)
Class/route: Haemophilus B and meningococcal conjugate vaccine; intramuscular
Indication: Prevent meningococcal disease and Haemophilus influenzae type B in children

Myrbetriq (NME)
(Mirabegron; Astellas Pharma US)
Class/route: Beta-3 adrenergic agonist; oral
Indication: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

Neutroval (BLA)
(tbo-filgrastim; Sicor Biotech UAB)
Class/route: Human granulocyte colony-stimulating factor; subcutaneous
Indication: To reduce the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia

Omontys (NME)
(Peginesatide acetate; Affymax/Takeda)
Class/routes: Erythropoiesis-stimulating agent;
subcutaneous, intravenous
Indication: Treatment of anemia associated with chronic kidney disease in adult patients on dialysis
Approval consideration: REMS
Update: This drug was removed from the market by the manufacturer on February 23, 2013

Perjeta (BLA)
(Pertuzumab; Genentech)
Class/route: HER2/neu receptor antagonist; intravenous infusion
Indication: Treatment of patients with HER2-positive metastatic breast cancer who have not received previous anti-HER2 therapy or chemotherapy for metastatic disease, to be used in combination with trastuzumab and docetaxel
Approval consideration: Priority review

Picato (NME)
(Ingenol mebutate; Leo Pharma)
Class/route: Antineoplastic; topical gel
Indication: Treatment of actinic keratosis

Prepopik (NME)
(Sodium picosulfate, magnesium oxide, anhydrous citric acid; Ferring Pharmaceuticals)
Class/route: Osmotic laxative; oral
Indication: For cleansing of the colon as a preparation for colonoscopy in adults

Signifor (NME)
(Pasireotide diaspartate; Novartis)
Class/route: Somatostatin analog; subcutaneous
Indication: Treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative
Approval consideration: Orphan drug

Sirturo (NME)
(Bedaquiline fumarate; Janssen Therapeutics)
Class/route: Diarylquinoline antimycobacterial; oral
Indication: For adults (≥18 years) with pulmonary multidrug-resistant tuberculosis, as part of a combination therapy, when an effective treatment regimen cannot otherwise be provided
Approval considerations: Priority review, orphan drug

Stendra (NME)
(Avanafil; Vivus)
Class/route: Phosphodiesterase type 5 inhibitor; oral
Indication: Treatment of erectile dysfunction

Stivarga (NME)
(Regorafenib; Bayer Healthcare Pharmaceuticals/Onyx Pharmaceuticals)
Class/route: Kinase inhibitor; oral
Indication: Treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan- based chemotherapy, and anti–vascular endothelial growth factor therapy, and, if KRAS wild type, an anti–endothelial growth factor receptor therapy
Approval consideration: Priority review

Stribild (NME)
(Elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate; Gilead)
Class/route: Integrase inhibitor antiretroviral; oral
Indication: A complete regimen for treatment of HIV-1 infection in adults who are antiretroviral treatment naïve

Surfaxin (NME)
(Lucinactant; Discovery Laboratories)
Class/route: Lung surfactant; intratracheal
Indication: Prevention of respiratory distress syndrome in premature infants at high risk for respiratory distress syndrome

Synribo (NME)
(Omacetaxine mepesuccinate; Teva)
Class/route: Protein synthesis inhibitor; subcutaneous
Indication: Treatment of adult patients with chronic- or accelerated-phase chronic myelogenous leukemia with resistance and/or intolerance to ≥2 TKIs
Approval consideration: Orphan drug

Tudorza Pressair (NME)
(Aclidinium bromide; Forest Laboratories)
Class/route: Anticholinergic; oral inhalation
Indication: Long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including bronchitis and emphysema

Vascepa (NME)
(Icosapent ethyl; Amarin Pharmaceuticals)
Class/route: Antihypertriglyceredemia; oral
Indication: Adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia

Voraxaze (BLA)
(Glucarpidase; BTG International)
Class/route: Carboxypeptidase enzyme; intravenous
Indication: Treatment of toxic plasma methotrexate concentrations (>1 µmol/L) in patients with delayed methotrexate clearance due to impaired renal function
Approval considerations: Priority review, orphan drug

Xeljanz (NME)
(Tofacitinib citrate; Pfizer)
Class/route: JAK inhibitor; oral
Indication: Treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to or intolerance of methotrexate
Approval consideration: REMS

Xtandi (NME)
(Enzalutamide; Astellas Pharma/Medivation)
Class/route: Androgen receptor inhibitor; oral
Indication: Treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel
Approval consideration: Priority review

Zaltrap (BLA)
(Ziv-aflibercept; sanofi-aventis US)
Class/route: Angiogenesis inhibitor; intravenous infusion
Indication: In combination with 5-fluorouracil, leuco­vorin, and irinotecan for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen
Approval consideration: Priority review

Zioptan (NME)
(Tafluprost; Merck Sharp & Dohme Corp)
Class/route: Prostaglandin analog; ophthalmic solution
Indication: To reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension


II. New Combinations, Formulations, Indications

Abraxane (new indication)
(Paclitaxel; Abraxis BioScience)
Class/route: Microtubule inhibitor; intravenous
New indication: First-line treatment of locally advanced or metastatic non–small-cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy; already indicated for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy

Afinitor (new indications)
(Everolimus; Novartis)
Class/route: mTOR kinase inhibitor; oral
New indications: Treatment of postmenopausal women with advanced hormone receptor–positive, HER2- negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole, and adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery; already indicated for the treatment of progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic; adults with advanced renal-cell carcinoma after failure with sunitinib or sorafenib; and pediatric and adult patients with tuberous sclerosis complex who have subependymal giant-cell astrocytoma
Approval consideration: Priority review

Afinitor Disperz (new formulation)
(Everolimus; Novartis)
Class/route: mTOR kinase inhibitor; oral
New formulation: Pediatric form, tablets for oral suspension
Indication: Treatment of pediatric patients aged ≥1 years with tuberous sclerosis complex who have subependymal giant-cell astrocytoma that requires therapeutic
intervention but cannot be curatively resected
Approval considerations: Priority review, orphan drug

Eylea (new indication)
(Aflibercept; Regeneron Pharmaceuticals)
Class/route: Recombinant fusion protein; ophthalmic intravitreal injection
New indication: Treatment of patients with neovascular (wet) age-related macular degeneration; already
indicated for the treatment of macular edema after
central retinal vein occlusion

Gleevec (new indication)
(Imatinib mesylate; Novartis)
Class/route: Kinase inhibitor; oral
New indication: Adjuvant treatment of adult patients after resection of Kit (CD117)-positive gastrointestinal stromal tumors (GISTs); already indicated for the treatment of CD117-positive unresectable and/or metastatic malignant GISTs; newly diagnosed adult and pediatric patients with chronic-, blast crisis–, accelerated-, or chronic-phase Ph-positive chronic myelogenous leukemia; relapsed or refractory Ph-positive acute lymphoblastic leukemia; myelodysplastic/myeloproliferative diseases; aggressive systemic mastocytosis without the D816V c-Kit mutation or with unknown c-Kit mutational status; hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1–platelet-derived growth factor receptor alpha fusion kinase; patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who are FIP1L1–platelet-derived growth factor receptor alpha fusion kinase negative or unknown; unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans

Humira (new indication)
(Adalimumab; Abbott Laboratories)
Class/route: Tumor necrosis factor blocker; subcutaneous
New indication: For inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis; already indicated to reduce the signs and symptoms of moderate-to-severe rheumatoid arthritis, moderate-to-severe active polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and moderate-to-severe chronic plaque psoriasis
Approval consideration: Orphan drug

Jentadueto (new combination)
(Linagliptin and metformin hydrochloride; Boehringer Ingelheim/Lilly)
Class/route: Dipeptidyl peptidase-4 inhibitor and biguanide combination; oral tablets
Indication: To improve glycemic control in adult patients with type 2 diabetes, as an adjunct to diet and exercise, when treatment with both linagliptin and meformin is appropriate

Levaquin (new indication)
(Levofloxacin; Janssen Pharmaceuticals)
Class/routes: Fluoroquinolone antibacterial; oral, intravenous
New indication: Treatment and prophylaxis of plague resulting from Yersinia pestis in adults and pediatric patients aged ≥6 months; already indicated for the treatment of pneumonia (nosocomial and community acquired), acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, skin and skin structure infections (complicated and uncomplicated), chronic bacterial prostatitis, urinary tract infections (complicated and uncomplicated), acute pyelonephritis, inhalational anthrax (postexposure)

Lucentis (new indication)
(Ranibizumab; Genentech)
Class/route: Vascular endothelial growth factor inhibitor; ophthalmic intravitreal injection
New indication: Treatment of diabetic macular edema; already indicated for the neovascular (wet) age-related macular degeneration and macular edema after retinal-vein occlusion

Qsymia (new combination)
(Phentermine hydrochloride and topiramate extended-release; Vivus)
Class/route: Combination sympathomimetic amine anorectic and antiepileptic; oral
Indication: For chronic weight management in adults with an initial body mass index of ≥30 kg/m2 (obese) or ≥27 kg/m2 (overweight) in the presence of ≥1 weight-related comorbidity, such as hypertension, type 2 diabetes mellitus, or dyslipidemia, as an adjunct to a reduced-calorie diet and increased physical activity
Approval consideration: REMS

Truvada (new indication)
(Emtricitabine, tenofovir disoproxil fumarate; Gilead)
Class/route: Nucleoside analog HIV-1 reverse transcriptase inhibitor; oral
New indication: In combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults at high risk; already indicated for the treatment of HIV-1 infection in adults and pediatric patients aged ≥12 years
Approval considerations: Priority review, REMS

Velcade Subcutaneous (new formulation)
(Bortezomib subcutaneous; Millennium)
Class/route: Proteasome inhibitor; subcutaneous
New formulation: Subcutaneous administration; already available as intravenous
Indication: Treatment of multiple myeloma or mantle-cell lymphoma in patients who have received at least 1 prior therapy; intravenous or subcutaneous administration
Approval considerations: Priority review, orphan drug

Votrient (new indication)
(Pazopanib hydrochloride; GlaxoSmithKline)
Class/route: Kinase inhibitor; oral
New indication: Treatment of patients with advanced soft-tissue sarcoma who have received prior chemotherapy; already indicated for the treatment of advanced renal-cell carcinoma

Xarelto (new indication)
(Rivaroxaban; Janssen Pharmaceuticals)
Class/route: Factor Xa inhibitor; oral
New indication: Treatment of deep-vein thrombosis, pulmonary embolism, and for the reduction in the risk of recurrence of deep-vein thrombosis and of pulmonary embolism; already indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the prophylaxis of deep-vein thrombosis, which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery
Approval consideration: REMS

Zetonna (new formulation)
(Ciclesonide; Sunovion)
Class/route: Corticosteroid; nasal aerosol
New formulation: Formulated with a hydrofluoroalkane propellant in a delivery system designed to dispense ciclesonide as a fine, dry mist in a small volume; already approved as Omnaris
Indication: Treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents aged ≥12 years

Zytiga (new indication)
(Abiraterone acetate; Janssen Biotech)
Class/route: Cytochrome P17 inhibitor; oral
New indication: Treatment of men with late-stage metastatic castration-resistant prostate cancer before chemotherapy, in combination with prednisone; already indicated for the treatment for patients whose prostate cancer progressed after chemotherapy containing docetaxel
Approval consideration: Priority review

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Last modified: August 30, 2021