Ranbaxy Laboratories receives US FDA approval to Manufacture and Market Hydrocodone Bitartrate & Acetaminophen Tablets USP

Ranbaxy Laboratories Ltd on August 20, 2007 has announced that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Hydrocodone Bitartrate and Acetaminophen Tablets USP, 75 mg/750 mg, 10 mg/500 mg, 5 mg/500 mg, and 10 mg/325 mg strengths. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drugs as follows:. 10 mg/325 mg Norco Tablets of Watson Pharmaceuticals Inc., 5 mg/500 mg Vicodin Tablets, and 7.5 mg/750 mg Vicodin ES Tablets both of Abbott Laboratories, and 10 mg/500 mg Lortab Tablets of UCB Inc. Total annual market sales for Hydrocodone Bitartrate and Acetaminophen Tablets were $ 390.6 million (IMS- MAT: June 2007).

"Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the relief of moderate to moderately severe pain and Ranbaxy is pleased to receive final FDA approval for multiple strengths of this product. These approvals further expand our product portfolio of affordable generic alternatives and will be launched in a November 2007 time period to all classes of trade," according to Jim Meehan, Vice President of Sales and Marketing for RPI.

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.

The stock was trading at Rs.365.75, up by Rs.13.15 or 3.73%. The stock hit an intraday high of Rs.367 and low of Rs.358.65. The total traded quantity was 210325 compared to 2 week average of 421574.

Source : Equity Bulls

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