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 Committee Says Gel Safe And Effective For Diabetic Ulcers BETHESDA, MD. -- July 15, 1997 -- The Dermatologic and Ophthalmic Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) today voted that Regranex(R) (becaplermin) Gel 0.01% is safe and effective for the treatment of diabetic ulcers that occur on the lower limbs and feet. A Biologic Licensing Application for Regranex Gel was filed in December 1996. The product was developed jointly by the R.W. Johnson Pharmaceutical Research Institute and Chiron Corp. The active ingredient in Regranex Gel is becaplermin, the genetically engineered form of platelet-derived growth factor, a naturally occurring protein in the body that stimulates wound healing. The data from the pivotal study presented during the Advisory Committee meeting showed that Regranex Gel 0.01%, applied once daily in combination with good wound care, significantly increased the incidence of complete healing by 43 percent when compared to placebo gel. Regranex Gel also significantly decreased the time to complete healing by 32 percent (six weeks). Regranex Gel was reported to be safe and well tolerated in clinical trials. Incidence of adverse events including infection and cellulitis was similar in patients treated with Regranex Gel, placebo gel or good wound care alone. Diabetic foot ulcers are a serious complication of diabetes affecting 1.5 million patients each year. More information on: Chiron Corp. E-mail this page to a friend or colleague! To print, use this version