Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

Ursodiol for PBC Recommended for Approval by the FDA MONTREAL—Nov. 5, 1996 -- Axcan Pharma Inc. (TSE;ME AXP) has crossed a major threshold towards obtaining authorization to market URSO(TM) (Ursodiol) for the treatment of primary biliary cirrhosis (PBC). Today the FDA's Gastrointestinal Expert Advisory Committee reviewed the results of clinical trials and recommended that the FDA approve it for this application. The recommendation was unanimous. Axcan will now await FDA approval, the final step before marketing the drug. The FDA's decision is expected quickly, possibly near the end of the present year or early in 1997. PBC is a chronic, progressive cholestatic liver disease of unknown origin. Some 50,000 people in the United States have the disease. At present, after diagnosis, patients survive an average of 10 years. Liver transplant is the only current treatment modality for end-stage patients. Findings indicate that URSO(TM) is the only effective and safe drug for the treatment of PBC. It improves the survival rate of patients free of liver transplantation and improves liver biochemistry. Axcan estimates the potential U.S. market for this application of URSO(TM) to range up to US $100 million in annual sales. The company will have seven years of market exclusivity in the United States due to URSO(TM)'s "orphan drug" status (a drug developed to treat a relatively small number of people with a rare disease). Axcan is involved in discussions with several U.S. pharmaceutical companies that are interested in marketing or co-marketing URSO(TM) in the U.S.A. A decision will be made shortly as Axcan firms up its plans to enter the U.S. market. Axcan Pharma is a pharmaceutical company which specializes in the field of gastroenterology and is also active in contraception, the prevention of sexually transmitted diseases and hemodialysis. Founded in 1983, its head office is located in Mont-St-Hilaire, (Quebec), and it has other offices and subsidiaries in Laval (Quebec), Calgary, (Alberta), and Plattsburgh, (New York). E-mail this page to a friend or colleague! To print, use this version