FDA approves Wockhardt enlarged prostate drug


PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for enlarged prostate made by generic drug maker Wockhardt, the company said.

Wockhardt, based in Mumbai, India, announced the approval of alfuzosin hydrochloride extended-release tablets in the 10-mg strength, which is designed to treat enlarged prostate, also known as benign prostatic hyperplasia.

The drug is a generic version of Sanofi's Uroxatral. Various versions of the drug have sales of about $81.5 million, according to IMS Health.

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