FDA approves Watson’s ANDA for generic ARTHROTEC

Jul 12 2012

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary Watson Laboratories, Inc - Florida has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium and Misoprostol Delayed-Release Tablets, the generic equivalent to G.D. Searle's ARTHROTEC®. Watson plans to launch the product in the fourth quarter of 2012.

For the twelve months ending May 31, 2012, ARTHROTEC® had total U.S. sales of approximately $130 million according to IMS Health data. ARTHROTEC® is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.

Source: Watson Pharmaceuticals, Inc.