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The FDA ha approved Salix Pharmaceuticals' Colazal (balsalazide disodium) for the treatment of mildly to moderately active ulcerative colitis in patients 5 to 17 years of age.
The FDA has approved Merck's Invanz (ertapenem), a once-daily injectable antibiotic, for the prophylaxis of surgical site infection following elective colorectal surgery in adults.
Labopharm has submitted a complete response to the approvable letter issued by the FDA for the company's once-daily formulation of tramadol, an opioid analgesic.
EpiCept has initiated a Phase I clinical study of EPC2407, a novel small-molecule vascular disruption agent and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas.
Neurocrine
Biosciences announced that under a collaboration with GlaxoSmithKline (GSK), GSK has initiated Phase II proof of concept clinical trials with a lead Corticotropin Releasing Factor R1 (CRF1) receptor antagonist compound for two indications: social anxiety disorder and irritable bowel syndrome (IBS).
Merck and Vertex Pharmaceuticals have announced the start of an international clinical trial of MK-0457 (also known as VX-680), an investigational small-molecule inhibitor of Aurora, FLT-3, JAK-2 and BCR-ABL kinases.
After reviewing data gathered to date as part of a planned interim analysis, an external data monitoring committee (DMC) has recommended that Eli Lilly's STEERING trial be closed for enrollment.
In observance of the holiday season, FDAnews Drug Pipeline Alert will not be published Friday, Dec. 22, Monday, Dec. 25, or Tuesday, Dec. 26. The next issue will be published Wednesday, Dec. 27.