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FDA Advisory Committee Splits On Combivent “Essential Use” Designation

This article was originally published in The Pink Sheet Daily

Executive Summary

Pulmonary-Allergy Drugs Committee votes 5-5, with two abstentions, that Boehringer Ingelheim’s Combivent should retain “essential use” designation. King’s Intal gets committee nod for essential use by slim margin. Committee votes to remove essential use designation for five CFC metered-dose inhalers drugs.
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