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New Delhi, Aug. 20 Ranbaxy Laboratories has said it has received approval to make and sell the generic version of the pain killer Hydrocodone Bitartrate and Acetaminophen. Abbot’s registered version of the drug sells as Viocodin.

According to Ranbaxy, the Office of Generic Drugs, US Food and Drug Administration, has granted it approval for four strengths of the Hydrocodone Bitartrate and Acetaminophen tablets. The total annual sales market for the drug is estimated at $390.6 million during the last financial year.

“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,” said Mr Jim Meehan, Vice President of Sales and Marketing of the company’s Florida subsidiary.

Ranbaxy’s 10 mg/325 mg strength has been determined bio equivalent to Watson Pharmaceuticals Inc’s Norco tablets, the 5 mg/500 mg and 7.5 mg/750 mg strength to be bio-equivalent to Abbott Laboratories’ Vicodin tablets and Vicodin ES tablets, and the 10 mg/500 mg strength to be bio equivalent to UCB Inc’s Lortab.

More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals | Ranbaxy Laboratories Ltd

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