Foradil Certihaler was recalled from the German and Swiss markets in January 2006 because of concerns that accidental mishandling of the device may have resulted in inaccurate dosing levels. The drug was modified and SkyePharma submitted it to the FDA. The FDA issued an approvable letter for Foradil Certihaler in April 2006.
SkyePharma earns a royalty on sales of Foradil Certihaler in all markets. Foradil Certihaler has been co-developed by SkyePharma and Novartis, and is a trademark of Novartis.
“We believe that this approval validates SkyePharma’s inhalation technology and paves the way to future products,” said Frank Condella, CEO of SkyePharma.