NEW DELHI: Drug firm Zydus Cadila today said it has received approval for the US health regulator to market Tadalafil tablets, used for the treatment of erectile dysfunction, in the American market.
The company has received tentative approval from the US Food and Drug Administration (USFDA) to market Tadalafil tablets USP in the strengths of 2.5 mg, 5 mg, 10 mg, and 20 mg, Zydus Cadila said in a statement.
The drug is indicated for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia, it added. The product would be manufactured at the group's formulations manufacturing facility at Moraiya, Ahmedabad.
The group now has now more than 170 approvals and so far filed over 310 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04. Shares of Cadila Healthcare, group's listed entity, were trading 0.43 per cent down at Rs 440.80 per scrip on BSE.