Wockhardt secures tentative nod from USFDA for Alfuzosin Hcl

WockhardtWockhardt, an Indian drugmaker, has secured tentative approval from the United States Food & Drug Administration (US FDA) for marketing the 10mg extended release tablets of Alfuzosin Hycdrochloride.

Alfuzosin, which is used for treating Benign Prostatic Hyperplasia (BPH or non-cancerous enlargement of prostate, is the generic name for the brand Uroxatral, marketed in the United States by Sanofi-Aventis.

It should be noted that the patent covering this product are under litigation in the US courts and Wockhardt will launch the product after resolution of the same.

The total market sale for Alfuzosin tablets in the US stands at about $203 million, as per IMS reports.

The shares of Wockhardt declined today Rs 6.65, or 3.42%, to settle at Rs 187.95 on BSE.