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 Darvocet A500 (Propoxyphene Napsylate And Acetaminophen) For Mild To Moderate Pain WILMINGTON, NC -- September 11, 2003 -- aaiPharma Inc. (Nasdaq: AAII) announced that it received confirmation today of U.S. Food and Drug Administration (FDA) approval of Darvocet A500™ (propoxyphene napsylate and acetaminophen) for the treatment of mild to moderate pain. Darvocet A500 is the only propoxyphene napsylate/acetaminophen combination product currently FDA approved that contains a lower (500 mg) dose of acetaminophen combined with 100 mg of propoxyphene napsylate, the same dose of propoxyphene napsylate found in Darvocet-N® 100. This new product will provide patients a unique Darvocet formulation with the safety benefits of less acetaminophen and the full power of propoxyphene. "Darvocet A500 will provide an important alternative for health care providers concerned about high acetaminophen intake in patients suffering from mild-to-moderate pain," commented Dr. Philip S. Tabbiner, President and CEO of aaiPharma. "Because the FDA has established a 4,000 mg maximum daily dose of acetaminophen for adults and physicians are concerned about patients who self medicate using over-the-counter products, we believe there is a significant market opportunity for this dose combination which contains less acetaminophen while retaining the full power of propoxyphene napsylate. This product is a clear illustration of our strategy to bring to market line extensions that make established products safer for patients and patient management easier for physicians." As previously announced, aaiPharma acquired the product from Athlon Pharmaceuticals. The Company is preparing for an immediate launch to the trade followed by a national launch of Darvocet A500 in October. Darvocet A500 contains 100 mg of propoxyphene napsylate and 500 mg of acetaminophen compared to the Darvocet-N 100 presentation, which contains 100 mg of propoxyphene and 650 mg of acetaminophen. The Darvocet-N 100 presentation, branded and generic, currently accounts for 95% of the more than $500 million total propoxyphene market, according to Verispan data. SOURCE: aaiPharma Inc. E-mail this page to a friend or colleague! To print, use this version