Drug firm Lupin today 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 USD 1,949.2 million in the US, Lupin said.
Tadalafil is indicated for treatment of erectile dysfunction and signs and symptoms of benign prostatic hyperplasia, it added.
Shares of Lupin were trading at Rs 804.50 per scrip on BSE, down 0.65 per cent from the previous close.
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