SkyePharma has announced a delay in the review of the European Marketing Authorisation Application (“MAA”) for the Flutiform fluticasone propionate/formoterol fumarate metered dose inhaler (MDI) because the 21 Concerned Member States failed to reach consensus during the designated time period. Mundipharma, which has licensed European rights to Flutiform, filed the MAA in March 2010.
According to SkyePharma, the majority of the Concerned Member States, including the UK, which is the Reference Member State for the review, had agreed to approve the application. A 60-day referral process will now be initiated to attempt to achieve consensus. The two companies say that they “are confident in the efficacy and safety profile of Flutiform, which is supported by the clinical evidence.”
Abbott Laboratories returned US rights for Flutiform to SkyePharma in August 2010 after discussions with the FDA regarding its complete response letter for the Flutiform NDA.
Read the SkyePharma press release.
