From USFDA
Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Nebivolol Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg, the generic version of Bystolic Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg, of Forest Laboratories, LLC [Forest]. With respect to 180-day generic drug exclusivity, the FDA noted that Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Nebivolol Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. Therefore, with this approval, Glenmark may be eligible for 180 days of generic drug exclusivity for Nebivolol Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg.Powered by Capital Market - Live News