FDA

Drug Maker Ordered to Shut DownAfter repeated infractions, a company is forced to shutter its doors.
FDA Approves 800 Generics in 2016, but Legislators Think Process Should Be FasterFDA set a record for generics approval, but is the process still too cumbersome?
FDA approves Epclusa (sofosbuvir/velpatasvir) for chronic hepatitis C infectionFDA approved EpclusaTM (sofosbuvir and velpatasvir, (SOF-VEL) for adults with chronic hepatitis C infection both with compensated cirrhosis or without cirrhosis as well as in combination with ribavirin for hepatitis C with decompensated cirrhosis.
Daclizumab approved for relapsing forms of multiple sclerosisDaclizumab is the first subcutaneous injectable monoclonal antibody to be approved for the treatment of MS.
Pharmacists support e-cigarette warningsMany pharmacists support FDA’s recent warning letters to drug stores, smoke shops, and other retailers over selling e-cigarettes, hookah tobacco, and cigars to minors.
New dosage form for migraine treatmentFDA approved Onzetra Xsail (Avanir Pharmaceuticals Inc.)— a fast-acting, low-dose sumatriptan dry powder formulation for the acute treatment of migraine with or without aura in adults.