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Boehringer Ingelheim's Combivent and Afrovent

Executive Summary

NDAs will be reviewed by FDA's Pulmonary-Allergy Drugs Advisory Committee on July 14-15. Data from NDA 20-291 for B-I's Combivent Inhalation Aerosol (ipratropium bromide/albuterol sulfate) will be reviewed for bronchospasm associated with chronic obstructive pulmonary disease. The committee also will be briefed on "general points to consider for inhalational drug product development," an upcoming Federal Register notice states. On July 15, the committee will review B-I's NDAs 20-393 and 20-394, respectively for Atrovent Nasal Spray .03% and .06%, for symptomatic relief of rhinorrhea associated with perennial rhinitis. The meeting will take place at FDA's Parklawn Building, conference rooms D&E, beginning at 8 a.m. both days
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