Celgene Corporation announced that as a result of Barr Laboratories, Inc, withdrawing its Abbreviated New Drug Application (ANDA) for thalidomide with the US Food and Drug Administration, the US District Court for the District of New Jersey has granted the requested dismissal of all claims and counterclaims in the thalidomide patent cases.
Thalomid (thalidomide) researched, developed and commercialized by Celgene Corporation, received US Food and Drug Administration (FDA) approval on May 25, 2006 as an oral treatment in combination with dexamethasone for patients newly diagnosed with multiple myeloma. Thalomid received FDA clearance in 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Thalomid is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.