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Alembic Pharma gets USFDA’s nod for Vardenafil Hydrochloride Orally Disintegrating Tablets

Alembic Pharmaceuticals has received an 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. Vardenafil Hydrochloride Orally Disintegrating Tablets are indicated for the treatment of erectile dysfunction. Alembic had previously received tentative approval for this ANDA.

Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg, have an estimated market size of $8 million for twelve months ending December 2017 according to IQVIA. Alembic now has a total of 78 ANDA approvals (65 final approvals and 13 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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