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Article: Foradil Certihaler receives approvable letter from FDA.
- Article from:
- Biotech Week
- Article date:
- November 19, 2003
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2003 NOV 19 - (NewsRx.com & NewsRx.net) -- SkyePharma PLC (SKYE) announced that the U.S. Food and Drug Administration (FDA) has issued an "approvable" letter for Foradil Certihaler (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 codeveloped by SkyePharma PLC and Novartis Pharma AG. The Foradil Certihaler was submitted for regulatory review in the U.S. in December 2002. Foradil Certihaler embodies two proprietary SkyePharma technologies, the Skyhaler, a novel breath-activated multidose dry powder inhaler (MDDPI) device, and Skyprotect, a ...