Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary of Ranbaxy Laboratories Ltd. (RLL, NSE: RANBAXY, BSE: 500359) ("Ranbaxy"), today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market Atorvastatin and has launched the product in the U.S. market.
Teijin Pharma Limited announced the European launch of TMX-67 (febuxostat), a novel drug discovered by Teijin Pharma for the treatment of hyperuricemia in patients with gout. Ipsen, a global biotechnology specialty care group and the TMX-67 licensee in Europe, and its sublicensee the Menarini Group, the first Italian pharmaceutical group in the world, have began marketing the product in Europe under the brand name ADENURIC(r).
TikoMed AB, a biotechnology company focused on development and commercialization of innovative treatments for immune diseases and cell therapies, today announced that IBsolvMIR® has been granted orphan drug designation for the prevention of graft rejection of pancreatic islet transplantation by the U.S. Food and Drug Administration (FDA).
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) announced today that Soliris(R) (eculizumab), its first-in-class complement inhibitor, has been granted Orphan Medicinal Product Designation by the European Commission for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS).
Schering-Plough Corporation (NYSE: SGP) announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for SYCREST(R) (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder.