Alembic Pharmaceuticals gets USFDA nod for erectile dysfunction drug

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26 Aug, 2025 12:21

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Drug firm Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator for Vardenafil Hydrochloride tablets, indicated for the treatment of erectile dysfunction.

The approved product is therapeutically equivalent to the reference listed drug product Levitra tablets of Bayer Healthcare Pharmaceuticals Inc.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA)Vardenafil Hydrochloride tablets in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, Alembic Pharmaceuticals said in a BSE filing.

Quoting IQVIA data, the company said, Vardenafil Hydrochloride tablets have an estimated market size of $35 million for twelve months ending June 2020.

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

Shares of Alembic Pharmaceuticals were trading 0.31 percent higher at Rs 1,020.30 apiece on the BSE.