The risks and benefits of indacaterol - The FDA's review

New England Journal of Medicine

Volumn 365, Issue 24, 2011, Pages 2247-2249

  Chowdhury, Badrul A ^a   Seymour, Sally M ^a   Michele, Theresa M ^a   Durmowicz, Anthony G ^a   Liu, Dongmei ^a   Rosebraugh, Curtis J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FORMOTEROL; GLUCOCORTICOID; INDACATEROL; PLACEBO; TIOTROPIUM BROMIDE; 5 (2 (5,6 DIETHYLINDAN 2 YLAMINO) 1 HYDROXYETHYL) 8 HYDROXY 1H QUINOLIN 2 ONE; 5-(2-(5,6-DIETHYLINDAN-2-YLAMINO)-1-HYDROXYETHYL)-8-HYDROXY-1H-QUINOLIN-2-ONE; BETA 2 ADRENERGIC RECEPTOR BLOCKING AGENT; INDAN DERIVATIVE; QUINOLONE DERIVATIVE;

ASTHMA; CHRONIC OBSTRUCTIVE LUNG DISEASE; DISEASE EXACERBATION; DOSE RESPONSE; DRUG APPROVAL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; FORCED EXPIRATORY VOLUME; HUMAN; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; ARTICLE; CHEMICALLY INDUCED DISORDER; DRUG SCREENING; INHALATIONAL DRUG ADMINISTRATION; METHODOLOGY; UNITED STATES;

ADMINISTRATION, INHALATION; ADRENERGIC BETA-2 RECEPTOR ANTAGONISTS; ASTHMA; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG APPROVAL; DRUG EVALUATION; HUMANS; INDANS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUINOLONES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84855176103     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1109621     Document Type: Review

References (5)

1. Drugs@FDA, FDA approved drug products: Arcapter Neohaler (indacaterol maleate). Silver Spring, MD: Food and Drug Administration (http://www. accessdata.fda.gov/ drugsatfda-docs/nda/2011/022383Orig1s000SumR.pdf).
2. Human medicines: Onbrez Breezhaler (indacaterol). London: European Medicine Agency (http://www.ema.europa.eu/ema/ index.jsp?curl=pages/medicines/ human/ medicines/001114/human-med-001219 .jsp&murl=menus/medicines/medicines .jsp&mid=WC0b01ac058001d124).
3. Barnes PJ, Pocock SJ, Magnussen H, et al. Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design. Pulm Pharmacol Ther 2010; 23:165-71.
4. Chowdhury BA, DalPan G. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med 2010; 362:1169-71.
5. Meeting materials of the March 8, 2011, meeting of the Pulmonary-Allergy Drugs Advisory Committee. Silver Spring, MD: Food and Drug Administration (http://www .fda.gov/AdvisoryCommittees/Committees MeetingMaterials/Drugs/ Pulmonary-Allergy DrugsAdvisoryCommittee/ucm238265.htm).