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Company Crane / GlaxoSmithKline / AEs / Novartis / ACM ACQ AE / AstraZeneca / / Country United States / United Kingdom / New Zealand / / Event FDA Phase / / Facility ACM ACQ AE ARG AUC BDP BHR BID cAMP CI COPD DSaRM ED EPR / Castle et al. / / IndustryTerm formoterol-containing products / salmeterol-containing products / proposed study protocol / / MedicalCondition increased asthma / usual asthma / Serious asthma / adenosine monophosphate Confidence interval Chronic / fatal asthma / asthma / / OperatingSystem OSE / / Organization Drug Safety and Risk Management Advisory Committee / GINA HFA HR ICS LABA NAEPP NHLBI OCS OR OSE PAC PADAC PC20 PEF QID QSPG RCT RR SABA SAE SMART SNPs SNS TDD US Advisory Committee / Pulmonary-Allergy Drugs Advisory Committee / office of Surveillance and Epidemiology Pediatric Advisory Committee Pulmonary-Allergy Drugs Advisory Committee Provocative / Pediatric Advisory Committee / FDA Joint Pulmonary-Allergy Drugs Advisory Committee / U.S. Food and Drug Administration / Advisory Committees / Pulmonary-Allergy Drug Advisory committee / Advisory Committee / / Person GINA HFA HR ICS LABA / / Position Executive / / Product fluticasone propionate / Advair HFA / Advair Diskus / Study medication / adenosine / albuterol / Symbicort / Serevent / Foradil / US / / Technology proposed study protocol / 41 Algorithm / 4.2 Algorithm / /
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U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. This content has not been altered or updated since it was archived