Alembic Pharmaceuticals receives USFDA Approval for Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg.
Deepthi | Myequity news | Date : 20-11-2018 11:00:00 IST
Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg (base). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Staxyn® Orally Disintegrating Tablets, 10 mg, of Bayer Healthcare Pharmaceuticals, Inc. Alembic had previously received tentative approval for this ANDA.
Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg, have an estimated market size of US$ 8 million for twelve months ending December 2017 according to IQVIA.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.