Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has won FDA abbreviated new drug application approval for Diclofenac Sodium and Misoprostol Delayed-Release Tablets.
The company plans to launch Diclofenac Sodium and Misoprostol Delayed-Release Tablets, the generic equivalent to GD Searle's Arthrotec, in the fourth quarter of 2012.
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.
According to IMS Health data, Arthrotec had total US sales of approximately $130m for the twelve months ending 31 May 2012.
Watson Pharmaceuticals is an integrated global specialty pharmaceutical company engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health.