FDA Approvals, News & Updates

Fluad, a trivalent vaccine produced using 3 flu virus strains—2 subtype A and 1 type B—has been approved for the prevention of seasonal influenza in patients aged ≥65 years. The vaccine was approved using the accelerated approval regulatory pathway.
Sugammadex (Bridion) injection has been approved by the US Food and Drug Administration to reverse the effects of neuromuscular-blocking drugs (rocuronium bromide and vecuronium bromide) used during tracheal intubation in adults. This injection may help patients recover from these drugs sooner.
Uridine triacetate (Vistogard) has been approved by the US Food and Drug Administration for emergency treatment of patients who receive an overdose of fluorouracil or capecitabine, or those who develop severe toxicities within 4 days of treatment with either therapy.
The US Food and Drug Administration has approved the oral drug alectinib (Alecensa) for the treatment of patients with metastatic, ALK-positive, non−small-cell lung cancer (NSCLC) who could not tolerate, or whose disease worsened after, receiving therapy with crizotinib (Xalkori).
At the end of November, the FDA approved elotuzumab (Empliciti) for use in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received 1 to 3 previous medications. Elotuzumab is the second FDA-approved monoclonal antibody for patients with multiple myeloma; the first agent (daratumumab) was approved earlier in the month.
On January 21, 2015, secukinumab (Cosentyx; Novartis), a human IL-17A antagonist, was approved by the US Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe plaque psoriasis.
Ixazomib (Ninlaro) has been approved for use in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 previous therapy. This is the first oral proteasome inhibitor to be approved for this patient population.
Daratumumab (Darzalex) received accelerated approval for patients with multiple myeloma who have received ≥3 treatments, according to the FDA. This is the first monoclonal antibody approved for multiple myeloma.
Lung cancer is the leading cause of cancer-related mortality in the United States among men and women. The most common type of the disease, non–small-cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases.
The US Food and Drug Administration (FDA) today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
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