FDA

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.
Why pharmacists are concerned about the safety of biosimilarsPharmacists and other healthcare professionals are looking to the FDA for more guidance on biosimilars and interchangeability with their reference products.
An overview of FDA’s 503B outsourcing facility requirementsFDA has stated that it intends to continue inspections of compounding pharmacies, and it has taken aggressive action, including enforcement actions, as appropriate to protect the public health.
FDA warns about oral antifungal use during pregnancyA Danish study has found a possibility of increased risk of miscarriage in pregnant women who use oral fluconazole to treat yeast infections.
FDA issues a new warning about popular diabetes drugFDA approves a new indication, then issues strengthened warning about possible effects.
FDA panel favors combo IR opioidWhile the panel recommended approval of the new product, it did not find sufficient evidence for abuse-deterrent labeling.