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Glaxo Flovent metered dose inhaler NDA should adhere to FDA guidance on reformulations -- Forest petition.

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GLAXO FLOVENT FORMULA SHOULD MEET STANDARDS IN FDA MDI GUIDANCE, FOREST Labs asserts in a Nov. 17 citizen petition to the agency. The petition, submitted on behalf of Forest Labs by the D.C. law firm of Kleinfeld, Kaplan & Becker, requests that FDA not approve Glaxo Wellcome's metered-dose inhaler product Flovent (fluticasone propionate) until the company conducts the types of studies laid out in FDA's 1994 "Points to Consider" document on development of MDI products ("The Pink Sheet" July 18, 1994, T&G-4).

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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