Wockhardt receives US FDA approval for prostrate drug
29 Sep 2009
The US FDA has granted tentative approval to wockhardt Ltd for marketing its 0.4mg tamsulosin hydrochloride capsules, used for treating benign prostatic hyperplasia (BPH or non-cancerous enlargement of prostate).
Tamsulosin is the generic name for the brand Flomax, marketed in the United States by Boehringer Ingelheim. Wockhardt says it would launch the product immediately after the patent cover on Flomaxl expires on 27 April 2010.
''Wockhardt has focused on developing products like tamsulosin, which involves complex modified-release technologies to gain competitive advantage,'' said Wockhardt chairman Habil Khorakiwala. ''This is our third NDDS product approval in the year and establishes our competency in such technologies. Both the API and the capsules require special manufacturing facilities and we are geared to meet the market demand,'' he further added.
Prostate enlargement is a common condition afflicting many men above a certain age and with the growing population of the elderly in the US, the demand will continue to increase.
According to IMS, the total market for tamsulosin capsules in the US is about $1,650 million and is one of the most used drugs to treat BPH.
In the US generic pharmaceutical market, Wockhardt has been consistently expanding its market share for all its products and it has endeavoured to be amongst the first-to-market companies for them.
The tamsulosin capsules will be manufactured at the US FDA-certified formulation plant at Chikalthana, Aurangabad, using active pharmaceuticfal ingredients also being manufactured by Wockhardt at its FDA approved plant.
Wockhardt developed the API and the capsules in-house.
