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Ranbaxy receives US FDA approval to manufacture and market Hydrocodone Bitartrate and Acetaminophen tablets USP |
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21 Aug 2007 |
Ranbaxy Laboratories Limited announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Hydrocodone Bitartrate and Acetaminophen Tablets USP
GURGAON, India | August 20, 2007 | Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 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 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.
SOURCE: Ranbaxy |
