FDA

Paliperidone and Clindamycin Recalls
Sodium Bicarbonate Injections RecalledThe recall is a major setback in the ongoing sodium bicarbonate shortage.
Phillips Recalling All Topical ProductsThe FDA found uncontrolled manufacturing practices.
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.
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.