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Posted on Aug 15, 08:31AM | UNI
Pharmaceutical firm Wockhardt today said it has received final approval from the United States Food and Drug Administration (US FDA) for marketing 10 mg extended release tablets of Alfuzosin hydrochloride, which is used in treatment of Benign Prostatic Hyperplasia (BPH) or enlarged prostate.
Alfuzosin is the generic name for the brand Uroxatral, marketed in the United States by Sanofi-Aventis.
Wockhardt is launching the product immediately.
According to IMS Health, the total market for this product in the US is about 81.5 million dollars. A substantial portion of men above the age of 60 suffer from BPH.
Wockhardt also markets other drugs in the same therapeutic group in the US.
"Developing extended release formulation has been a core competency of Wockhardt's R and D over the years," Dr Habil Khorakiwala, Wockhardt Founder Chairman and Group CEO, said in a statement.
"Extended Release Alfuzosin is yet another product in the NDDS technology space," he added.
Wockhardt will be manufacturing the Alfuzosin hydrochloride API in its facility at Ankleshwar, India and the extended-release tablets of Alfuzosin at its facility in Aurangabad.
The technology for the API and the capsules were developed in-house.