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Wockhardt wins marketing approval for generic BPH drug

The US FDA has granted Wockhardt marketing approval for 10mg extended release tablets of Alfuzosin hydrochloride, which is used in treatment of Benign Prostatic Hyperplasia (BPH) or enlarged prostate.

Wockhardt will manufacture the Alfuzosin hydrochloride API in its Ankleshwar facility and the extended-release tablets of Alfuzosin at its facility in Aurangabad, India. The technology for the API and the capsules were developed in-house.

Wockhardt founder chairman and Group CEO Habil Khorakiwala said, "Extended Release Alfuzosin is yet another product in the NDDS technology space."

According to IMS Health, the US market of the product is about $81.5m. A substantial portion of men above the age of 60 suffer from BPH.