Zydus Cadila has received approval from the US health regulator to market Tadalafil tablets, used for treating erectile dysfunction, in the American market.
The company has received tentative approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, Zydus Cadila said in a regulatory filing today.
Tadalafil tablets are used to treat erectile dysfunction and symptoms of enlarged prostate.
The company will manufacture the product from its Moraiya, Ahmedabad-based facility. Zydus group now has more than 195 approvals and has so far filed over 330 abbreaviated new drug applications (ANDAs) since 2003-04.
Shares of Cadila Healthcare, the group’s listed entity, ended the session up by 2.23 per cent at Rs 409.50.