Ranbaxy Pharmaceuticals has announced that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Tamsulosin Hydrochloride Capsules, 0.4 mg.
Tamsulosin HCl capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Total annual market sales for Flomax(R), Tamsulosin HCl capsules were $1.1 billion (IMS - MAT: March 2007).
"This tentative approval granted by the 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.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.
Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies", resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.