SkyePharma admits defeat over Certihaler

12 January 2009

The UK's SkyePharma has abandoned discussions with the US Food and Drug Administration over the commercialization of the approved  formoterol inhaler Certihaler after the Joint Advisory Committee  recommended to the FDA that the benefits did not outweigh the risk in  the current asthma indications for long-acting beta agonists  administered alone. Cessation of production of the inhaler will result  in charges of between L7.0 million ($10.2 million) and L8.0 million to  SkyePharma, the firm says. Chief executive Ken Cunningham said that the  company "remain[s] confident of the prospects of our other pipeline  products including Flutiform (fluticasone/formoterol), which remains on  track for filing in the first quarter of 2009."

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