Ranbaxy Laboratories Ltd on June 22, 2007 has announced that the Company has received tentative approval from the U.S. Food and Drug Administration (US FDA) to manufacture and market Tamsulosin Hydrochloride Capsules, 0.4 mg. Tamsulosin IICI capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. Total annual market sales for Flomax®, Tamsulosin HCI capsules were $ 1.1 billion (IMS - MAT : March 2007).
"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 Jim Meehan, Vice President of Sales and Marketing for RPI, USA.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of the Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
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