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FDA Approves Foradil(R) Certihaler(TM) (Formoterol Fumarate Inhalation Powder)
LONDON, UK -- December 18, 2006 -- SkyePharma PLC announces today that the US Food and Drug Administration (FDA) has approved Foradil(R) Certihaler(TM) (formoterol fumarate inhalation powder) for the treatment of asthma. Foradil(R) Certihaler(TM) has been co-developed by SkyePharma and Novartis, and is a trademark of Novartis.
The FDA issued an 'approvable' letter for Foradil(R) Certihaler in April 2006. Following a recall from the German and Swiss markets in January 2006 because of concerns that accidental mishandling of the device may have resulted in inaccurate dosing in a small number of cases. The device was modified and the modifications were submitted to the FDA.
The Foradil(R) Certihaler(TM) has been approved in 27 countries outside the USA, and SkyePharma is in discussion with Novartis with respect to commercial launch in these territories.
SkyePharma earns a royalty on sales of Foradil(R) Certihaler(TM) in all markets. SkyePharma also manufactures and supplies the Foradil(R) Certihaler(TM).
Frank Condella, CEO, SkyePharma said: "We are extremely pleased by the FDA's decision to approve the modifications to Foradil(R) Certihaler(TM). We believe that this approval validates SkyePharma's inhalation technology and paves the way to future products."
SOURCE: SkyePharma
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