Watson Receives FDA Approval For Generic Combunox
Watson Pharmaceuticals has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride and Ibuprofen Tablets (CII) in the 5 mg/400 mg strength.
Watson's Oxycodone Hydrochloride and Ibuprofen product is the generic equivalent to Forest Laboratories Inc.'s Combunox, which is indicated for the short-term (not more than 7 days) management of acute, moderate to severe pain.
For the 12-months ending September 2007, Combunox had total U.S. sales of approximately $4 million, according to IMS Health data. Watson intends to launch its Oxycodone Hydrochloride and Ibuprofen product immediately.