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Pharma & Bio Ingredients
The FDA issued an "approvable" letter for Foradil 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 Certihaler 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 Certihaler in all markets. SkyePharma also manufactures and supplies the Foradil Certihaler.
"We are extremely pleased by the FDA's decision to approve the modifications to Foradil Certihaler, said Frank Condella, CEO, SkyePharma. "We believe that this approval validates SkyePharma's inhalation technology and paves the way to future products."
