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Barr Applies for FDA Approval for Generic Thalomid


Posted on 2006-12-26 10:36:00



Barr Pharmaceuticals Inc.'s Barr Labs unit said Tuesday it applied for FDA approval for a generic version of Celgene Corp.'s Thalomid drug in 50 milligram and 100 milligram doses.

Celgene markets thalidomide to treat erythema nodosum leprosum, a condition in patients with borderline and lepromatous leprosy. The drug is also approved as a treatment for multiple myeloma, a bone marrow cancer for which there is currently no cure.

Barr already filed an application with the Food and Drug Administration for approval of a 200 milligram version, prompting Celgene to file a complaint alleging patent infringement.

Thalomid capsules had sales of $424 million for the 12 months ended Oct. 31, according to Barr.