Alembic Pharmaceuticals today announced that the Company 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 (RLD), Levitra Tablets, 2.5 mg, 5 mg, 1 O mg, and 20 mg, of Bayer Healthcare Pharmaceuticals Inc. (Bayer).
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 now has a total of 127 ANDA approvals (112 final approvals and 15 tentative approvals) from USFDA.