Lupin gets USFDA nod to Sildenafil tablets to treat erectile dysfunction

Sildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). The product is a generic version of PfizerInc's Viagra tablets.

New Delhi: Drug firm Lupin Monday said it has received approval from the US health regulator to market Sildenafil tablets, used in the treatment of erectile dysfunction, in the American market.

The company has received the approval from the US Food and Drug Administration (USFDA) to market its product which is a generic version of PfizerInc's Viagra tablets, Lupin Ltd said in a regulatory filing.

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The Mumbai-based company has received approval for its product in various strengths, it added.

Sildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).

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According to IQVIA MAT December 2018 data, Sildenafil tablets USP, 25 mg, 50 mg, and 100 mg had annual sales of around USD 611 million in the US market.

Headquartered in Mumbai, Lupin develops and delivers a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a position in the Anti-TB segment.

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