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The FDA has approved the first generic version of Wellbutrin XL (bupropion hydrochloride), which is indicated for the treatment of major depressive disorder.
Barr Laboratories has filed an abbreviated new drug application to manufacture and market a generic version of Celgene's Thalomid (thalidomide) capsules, 200 mg.
Encysive Pharmaceuticals announced it has provided the information requested by the FDA in its most recent letter to the company regarding the its response to an approvable letter for Thelin (sitaxsentan sodium) 100-mg tablets.
Epix Pharmaceuticals has announced it will submit a formal appeal to the director of the FDA's Center for Drug Evaluation and Research (CDER) asking the director to overrule the decision by the Office of New Drugs (OND) denying a previously submitted appeal for its blood-pool imaging agent Vasovist (gadofosveset trisodium injection).
Genta announced it has received notice that its new drug application (NDA) for the use of Genasense plus chemotherapy in patients with chronic lymphocytic leukemia (CLL) has been deemed not approvable by the FDA.
Biopure has announced that the FDA's Blood Products Advisory Committee voted 11-8 to recommend against proceeding with the Navy's proposed Phase IIb/III, 1,100-patient study of Biopure's oxygen therapeutic Hemopure (hemoglobin glutamer 250 (bovine)) for the pre-hospital treatment of hemorrhagic shock resulting from traumatic injury.
MGI Pharma and its partner Helsinn Healthcare have announced the successful completion of two Phase III trials of Aloxi (palonosetron hydrochloride) injection for the prevention of postoperative nausea and vomiting.