Alembic Pharmaceuticals receives USFDA Final Approval for Vardenafil Hydrochloride Tablets, 2.5 mg (base), 5 mg (base), 10 mg (base), and 20 mg (base)

Alembic Pharmaceuticals Limited 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, 10 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.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.1017.15 as compared to the previous close of Rs. 989.35. The total number of shares traded during the day was 82701 in over 6023 trades.

The stock hit an intraday high of Rs. 1035 and intraday low of 984.25. The net turnover during the day was Rs. 84302603.

Source : Equity Bulls

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