Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) vardenafil hydrochloride tablets, 2.5 mg (base), 5 mg (base), 10 mg (base), and 20 mg (base).

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Levitra tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg, of Bayer Healthcare Pharmaceuticals Inc.

Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.

Vardenafil hydrochloride tablets have an estimated market size of US$ 35 million for twelve months ending June 2020, according to IQVIA.

Alembic has a total of 127 ANDA approvals (112 final approvals and 15 tentative approvals) from US FDA.