SkyePharma OK'D on Asthma Inhaler
Posted on: Monday, 18 December 2006, 12:01 CST
British firm SkyePharma said it has been approved for U.S. sales of Foradil Certihaler for the treatment of asthma.
The formoterol-fumarate, inhalation powder-based inhaler was co-developed by SkyePharma and Novartis, and is a trademark of Novartis.
The companies were able to secure final approval of the inhaled treatment from the Food and Drug Administration after a glitch earlier in the year that delayed the product's launch in the United States.
The Foradil Certihaler had been recalled from the market in Germany and Switzerland in January due to concerns that product mishandling may have caused inaccurate dosing in some units.
The incident prompted the FDA to issue an approvable letter for the device in April, rather than granting full approval. The device was modified and the changes submitted to the FDA, SkyePharma said.
The Foradil Certihaler is approved in 27 countries outside the United States, and SkyePharma noted it is talking with Novartis regarding commercial launch in these markets.
SkyePharma earns a royalty on sales of the inhaler in all markets and also manufactures and supplies the product.
Source: United Press International
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