India-headquartered Ranbaxy Pharmaceuticals (RPI) has won FDA approval to manufacture and market two analgesic drugs.
The FDA approval permits Ranbaxy to produce different dosages of hydrocodone bitartrate and acetaminophen for the treatment of moderate to moderately severe pain.
The approved drugs are bio-equivalent copies of Norco, Vicodin and Lortab, the annual market sales of which were USD 391m.
Jim Meehan, vice-president of sales and marketing for RPI, said: "These approvals further expand our product portfolio of affordable generic alternatives and will be launched in a November 2007 time period."
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