FDA has approved the first medication therapy, mifepristone (Korlym, Corcept Therapeutics), for endrogenous Cushing?s syndrome, a condition that, left untreated, has a mortality rate of 50 percent after 5 years.
FDA has approved an intravitreal injection to treat patients with wet AMD and zolpidem to treat insomnia.
FDA approved sitagliptin and metformin hydrochloride (HCl) extended-release (Janumet XR, Merck) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.
FDA has approved linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets, a new tablet that provides a single-tablet treatment option, taken twice-daily, for adult patients who need to control their blood sugar.
FDA approved ivacaftor (Kalydeco, Vertex Pharmaceuticals) for the treatment of a rare form of cystic fibrosis in patients aged 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator gene.
Indian drug giant Ranbaxy has accepted a consent decree filed by the U.S. Department of Justice on behalf of FDA. The decree, which must still be accepted by the U.S. District Court for the District of Maryland, requires Ranbaxy to fix long-standing manufacturing problems at plants in India as well as a plant in the United States.
FDA approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets).
FDA approved zolpidem tartrate sublingual tablets (Intermezzo, Transcept Pharmaceuticals) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.
FDA has approved aflibercept (Eylea Injection, Regeneron), known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration in patients aged 60 and older at a recommended dose of 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).
FDA approved ruxolitinib (Jakafi, Incyte) for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.