Lupin gets USFDA approval for generic erectile dysfunction drug
New Delhi: Drug firm Lupin said it has received tentative approval from the US health regulator for its Tadalafil tablets, indicated for treating erectile dysfunction and prostate gland enlargement.
The clearance from the United States Food and Drug Administration (USFDA) is for marketing Tadalafil tablets in strengths of 2.5 mg, 5 mg, 10 mg, and 20 mg, in the US, Lupin said in a statement.
The product is a generic version of Eli Lilly and the company's Cialis tablets in the same strengths, it added.
As per IQVIA MAT April 2018 data, Tadalafil tablets in these strengths had annual sales of around $1,949.2 million in the US, Lupin said.
Tadalafil is indicated for the treatment of erectile dysfunction and signs and symptoms of benign prostatic hyperplasia, it added.
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