Wockhardt gets USFDA nod for generic Uroxatral
New Delhi: Drug firm Wockhardt on Tuesday said it has received approval from the American health regulator USFDA to market Alfuzosin hydrochloride tablets, used in treating enlarged prostate, in the US market.
The company has received a final approval from US Food and Drug Administration (USFDA) for marketing 10 mg extended release tablets of Alfuzosin hydrochloride, Wockhardt said in a statement.
"Wockhardt is launching the product immediately," it added.
Alfuzosin is the generic name for the brand Uroxatral, marketed in the United States by Sanofi-Aventis. According to IMS Health data, the total market for this product in the US is about USD 81.5 million.
"Developing extended release formulation has been a core competency of Wockhardt's R&D over the years. Extended Release Alfuzosin is yet another product in the NDDS technology space," Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said.
Wockhardt will produce the Alfuzosin hydrochloride tablets at its facility in Aurangabad, the company said.
Shares of Wockhardt today touched a new high of Rs 1,240 on the BSE, up 3.40 percent from their previous close.