Orphan Europe and CMIC sign a Collaboration Agreement
News
The 22/12/2008 at 16:15:13
Paris, France and Tokyo, Japan, 16th December 2008.
Orphan Europe SARL and CMIC Co., Ltd. have signed a Collaboration and License Agreement regarding the development, registration and marketing of Normosang® (human hemin) for the treatment of acute attacks of hepatic porphyria in the Japanese market.
Orphan Europe Filed Carbaglu NDA with the FDA in the U.S.
The 21/04/2008 at 12:11:17
Recordati announced the submission to the U.S. FDA by Orphan Europe (a Recordati group company) of an Original New Drug Application (NDA) for Carbaglu® (carglumic acid). The NDA provides for the safe and effective use of Carbaglu® in the treatment of hyperammonaemia due to an autosomal genetic disorder resulting in the deficiency of the liver enzyme N-acetylglutamate synthase (NAGS deficiency).
FDA designates Carbaglu® for treatment of NAGS deficiency as a Fast Track product.
The 10/07/2007 at 12:28:28
The Food and Drug Administration in the USA has concluded that Carbaglu® (carglumic acid) for treatment of N-acetylglutamate synthase (NAGS) deficiency meets the criteria for fast track designation.
Carbaglu®, an Orphan Europe Product Receives the "Pilule d'Or".
The 28/01/2008 at 16:14:34
The prestigious French review Prescrire rewarded the most important medicines in 2007 and awarded the “Pilule d’Or” (the golden pill), its highest distinction, to Carbaglu® (carglumic acid), an Orphan Europe product.
