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

FDA Approves Change in Storage Conditions for Humate-P BETHESDA, MD -- October 22, 2007 -- The U.S. Food and Drug Administration approved a change in the storage conditions for Humate-P, a treatment for bleeding in certain patients with hemophilia A or von Willebrand Disease (vWD). The treatment, a protein that helps blood form the clots necessary to stop bleeding, can now be safely stored for up to two years at 77 degrees Fahrenheit. Previously, Humate-P required colder, refrigerator-level temperatures for that storage length. Approval of this change was based on stability data submitted by the company including laboratory tests of product potency conducted under different temperatures. "The change in storage conditions will help patients, their families and treating physicians better manage the product, especially as part of medically supervised home treatment programs," said Jesse L. Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research. Humate-P is approved for the treatment and prevention of bleeding in adult patients with hemophilia A, a rare clotting disorder. It is also approved for the treatment of spontaneous and trauma-induced bleeding and the prevention of excessive bleeding related to surgery in adult and pediatric patients with vWD, the most common inherited bleeding disorder in the United States. Humate-P is manufactured from human plasma obtained from screened and tested U.S. donors. Reported adverse reactions include allergic reactions such as hives, rash, chest tightness, swelling, and shock. Blood clots have been observed in patients under treatment for vWD. Humate-P was first approved in 1986 for the treatment and prevention of bleeding in patients with hemophilia A. It was first approved for use in patients with vWD in 1999. The product is manufactured by CSL Behring GmbH in Marburg, Germany. SOURCE: U.S. Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version