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Alembic Pharmaceuticals receives USFDA Final Approval for Vardenafil Hydrochloride Tablets

Alembic Pharmaceuticals today announced that the Company has received final approval from the US Foo

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.

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