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Boehringer Ingelheim's Combivent

Executive Summary

Company is understood to have received a lengthy "not approvable" letter from FDA Feb. 23 for its ipratropium bromide/albuterol sulfate combination product. FDA's concerns regarding the Combivent inhalation aerosol NDA apparently include production and GMP issues, as well as the need for additional safety data on coadminstration of the two drug components. Boehringer Ingelheim filed its NDA (20-291) for the bronchodilator May 23, 1993 for the treatment of bronchospasms associated with chronic obstructive pulmonary disease

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