Amneal gets approval for generic version of Ortho Evra
BRIDGEWATER, N.J.— Amneal Pharmaceuticals has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for 150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol transdermal system. In conjunction with its approval, Amneal received a Competitive Generic Therapy (CGT) designation by the FDA and has been granted 180 days of exclusivity.
