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 Budesonide/Formoterol Fumarate Dihydrate for COPD NEW YORK -- February 27, 2009 -- The US Food and Drug Administration (FDA) has approved budesonide/formoterol fumarate dihydrate (Symbicort) 160/4.5 mcg for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The approval is based on results from 2 pivotal phase 3 trials that evaluated more than 3,600 patients aged 40 years and older with moderate to very severe COPD. The studies demonstrated that patients using budesonide/formoterol fumarate dihydrate 160/4.5 mcg had significantly greater mean improvements from baseline in predose forced expiratory volume in 1 second (FEV1) averaged over the treatment period compared with formoterol 4.5 mcg and placebo. Patients taking budesonide/formoterol fumarate dihydrate had significantly greater mean improvements from baseline in 1-hour postdose FEV1 averaged over the treatment period compared with budesonide 160 mcg and placebo. Furthermore, the median time to onset of significant bronchodilation (>=15% improvement in FEV1) was 5 minutes. Budesonide/formoterol fumarate dihydrate was generally well tolerated over the 12-month study, and the incidence of pneumonia was no different for patients taking budesonide/formoterol fumarate dihydrate compared with placebo-treated patients. There was a higher incidence of potential lung infections other than pneumonia (eg, bronchitis and viral lower respiratory tract infections) in patients receiving budesonide/formoterol fumarate dihydrate than in those receiving formoterol or placebo. The most common drug-related adverse events reported were nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and viral upper respiratory tract infection. SOURCE: AstraZeneca E-mail this page to a friend or colleague! To print, use this version