From USFDA
Alembic Pharmaceuticals has received tentative approval from the USFDA for its Abbreviated New Drug Application for Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product STAXYN Orally Disintegrating Tablets, 10 mg of Bayer Healthcare and is used under license by GlaxoSmithKline. Vardenafil Hydrochloride Orally Disintegrating Tablets are indicated for treatment of erectile dysfunction.Powered by Capital Market - Live News