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Lupin receives FDA approval for Sildenafil Tablets USP

Mumbai, Baltimore, March 25, 2019: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg from the United States Food and Drug Administration (FDA) to market a generic version of Pfizer Inc’s Viagra Tablets, 25 mg, 50 mg, and 100 mg.

Lupin’s Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg, is the generic version Pfizer Inc’s Viagra Tablets, 25 mg, 50 mg, and 100 mg. Sildenafil Tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).

Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg had an annual sales of approximately USD 611 million in the US (IQVIA MAT December 2018).

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