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).
December 13th 2007 - Recordati S.p.A. announced the successful conclusion of its acquisition of Orphan Europe announced on 28 September last, following clearance from the relevant anti-trust authorities. The purchase price is € 135 million.
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.
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.
Treatment of Rare Disorders Accessible in the Middle East.
News
The 06/02/2007 at 13:45:07
Orphan Europe strengthens its presence in the Middle East by opening a subsidiary at Dubai Health Care City. Local staff and stocking facilities will ensure better support and service for patients and physicians in the region.
Orphan Europe acquires world-wide rights to Cystadane®, an orphan drug for treatment of homocystinuria, from Jazz Pharmaceuticals, Inc.
News
The 19/03/2007 at 10:48:33
Cystadane® has marketing approval in the US, Canada, Australia and Israel. On the 15th of February 2007, Orphan Europe received marketing authorization for Cystadane® in Europe.
Orphan Europe and Peptimmune Partner to Develop Specific Immunotherapy for Life-Threatening Skin Disease
News
The 06/02/2007 at 13:45:46
Orphan Europe sarl and Peptimmune Inc. have signed a Scientific Collaboration and License Agreement regarding the development of a peptide immunotherapy for the treatment of pemphigus vulgaris.
