The United States Food and Drug Administration has approved Watson Laboratories, Inc's 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 US 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.