Business Daily from THE HINDU group of publications
Saturday, Jun 23, 2007
ePaper
Business Daily from THE HINDU group of publications Saturday, Jun 23, 2007 ePaper |
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Corporate
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Regulatory Bodies & Rulings
Our Bureau,
New Delhi June 22 Ranbaxy Laboratories has received tentative approval to sell generic version of the Flomax in the US, and is also hopeful of being granted a 180-day marketing exclusivity for it. In a statement, the Gurgaon-based company said that the US Food and Drug Administration has given it tentative approval to manufacture and market tamsulosin hydrochloride capsules, of 0.4 mg indicated for the treatment of benign prostatic hyperplasia (BHP), an enlargement of the prostate gland that causes urinary symptoms. The total annual market sales for the German pharma company Boehringer Ingelheim's registered drug were estimated at $1.1 billion, according to Ranbaxy. "This tentative approval granted by the US FDA under the Medicare Modernization Act (MMA) will provide Ranbaxy with an opportunity to market tamsulosin capsules to all classes of trade at the time of final approval. We anticipate introducing this formulation with a 180-day period of exclusivity assuming the successful resolution of the patent litigation regarding this product," said Mr Jim Meehan, Vice-President of Sales and Marketing for the company's Florida based subsidiary, Ranbaxy Pharmaceuticals Inc.
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