PRINCETON, N.J. The Food and Drug Administration has granted approval to Ranbaxy Laboratories for the manufacture and market of 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, Ranbaxy Pharmaceuticals announced today.
The FDA’s Office of Generic Drugs determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drugs as follows: Watson Pharmaceuticals’ Norco, Abbott’s Vicodin and Vicodin ES tablets and UCB’s Lortab tablets.
Total annual market sales for hydrocodone bitartrate and acetaminophen tablets were $390.6 million, according to IMS data.
"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," stated Jim Meehan, vice president of sales and marketing for Ranbaxy. "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."