Zydus Cadila gets USFDA nod for erectile dysfunction drug
New Delhi: Drug firm Zydus Cadila said it has received approval from the US health regulator to market Tadalafil tablets, used to 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 strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, Zydus Cadila said in a regulatory filing.
Tadalafil tablets are used to treat erectile dysfunction and symptoms of enlarged prostate.
The drug firm 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 abbreviated new drug applications (ANDAs) since 2003-04.
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