Mylan announced that the Food and Drug Administration (FDA) has approved Nevirapine Extended-Release Tablets, the generic version of Boehringer Ingelheim's Viramune XR.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for NBI-98854 (Neurocrine Biosciences) for tardive dyskinesia.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to RST-001 for the treatment of retinitis pigmentosa (RP).
TWi Pharmaceuticals announced it has received final approval from the Food and Drug Administration (FDA) for Donepezil HCl Tablets, the generic version of Eisai's Aricept.
AstraZeneca announced that the FDA has approved Xigduo XR (dapagliflozin and metformin HCl extended-release) for adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.