Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) 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, Levitra tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg, of Bayer Healthcare Pharmaceuticals.
Vardenafil Hydrochloride Tablets are indicated for the treatment of erectile dysfunction. They have an estimated market size of $35 million for twelve months ending June 2020 according to IQVIA.
Alembic now has a total of 127 ANDA approvals (112 final approvals and 15 tentative approvals) from USFDA.