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Article: FORADIL(R) CERTIHALER(TM) Receives 'Approvable' Letter From FDA.
- Article from:
- PR Newswire
- Article date:
- October 22, 2003
CopyrightCOPYRIGHT 2003 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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SkyePharma PLC announced today that the US Food and Drug Administration ("FDA") has issued an "approvable" letter for FORADIL(R) CERTIHALER(TM) (formoterol fumarate inhalation powder). This means that the product can be approved by the FDA subject to resolution of certain outstanding issues. The FORADIL CERTIHALER was co-developed by SkyePharma PLC and Novartis Pharma AG. The FORADIL CERTIHALER was submitted for regulatory review in the US in December 2002. FORADIL(R) CERTIHALER(TM) embodies two proprietary SkyePharma technologies, the SKYEHALER(TM), a novel breath-activated multi-dose dry powder inhaler (MDDPI) device, and SKYEPROTECT(TM), a powder formulation that ...