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Medicine / Chemistry / Benzamides / Organofluorides / Pyridines / Roflumilast / Chronic obstructive pulmonary disease / Acute exacerbation of chronic obstructive pulmonary disease / Chronic bronchitis / Health / Chronic lower respiratory diseases / Smoking


FDA ERRATA (dated[removed]To FDA Advisory Committee Briefing Documents PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE MEETING April 7, 2010 NDA[removed]: Daxas (roflumilast 500 mcg tablets)
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Forest Laboratories / AEs / ITT / /

IndustryTerm

roflumilast dose groups / roflumilast 500mcg / treatment of chronic obstructive pulmonary disease / placebo / /

MedicalCondition

Safety/Cancer / total tumor / tremor / pancreatitis SAEs / tumor / severe COPD / birth defect / In COPD / adenocarcinomas / acute pancreatitis SAEs / COPD / pancreatitis / diarrhea / diarrhea SAEs / chronic obstructive pulmonary disease / inflammation / acute pancreatitis / depression / intractable diarrhea / cancer/tumors / undifferentiated carcinomas / sputum production bronchitis / nausea / minimal acute inflammation / chronic bronchitis / /

Organization

FDA / To FDA Advisory Committee Briefing Documents PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE / /

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