In Brief: FDA June "approvables"
Executive Summary
FDA June "approvables": Janssen's Propulsid suspension (cisapride monohydrate) deemed "approvable" June 13. NDA 20-398 covers two strengths of the new formulation, 1 mg base/mL and 2 mg base/mL. The upper GI tract motility stimulator is approved in tablet form. On June 22, FDA grants "approvable" status to Boehringer Ingelheim's Atrovent (ipratropium bromide) .021 mg for symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis and .042 mg metered-dose spray for symptomatic relief of rhinorrhea associated with the common cold. Atrovent is currently indicated for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema...