(By Balaseshan) Watson Pharmaceuticals Inc. (NYSE:WPI) said its subsidiary has received approval from the U.S. regulatory authorities for the generic steoarthritis or rheumatoid arthritis drug.
Watson Laboratories Inc. - Florida has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for diclofenac sodium and misoprostol delayed-release tablets.
Watson plans to launch the product in the fourth quarter of 2012. Diclofenac sodium and misoprostol delayed-release tablets is the generic equivalent to G.D. Searle's ARTHROTEC.
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.
For the twelve months ending May 31, 2012, ARTHROTEC had total U.S. sales of approximately $130 million according to IMS Health data.
Watson is an integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic and brand pharmaceutical products. It operates in three segments: Global Generics, Global Brands and Distribution.
WPI ended Wednesday's regular session down 0.16% at $74.70. The stock has been trading between $55 and $77.73 for the past 52 weeks.