The Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting regarding Breo Ellipta originally scheduled for March 7, 2013 has been rescheduled for April 17, 2013, from 8 am to 5 pm. The meeting was rescheduled due to weather concerns.
The purpose of the meeting is to discuss GSK’s new drug application for its fluticasone furoate/vilanterol dry powder inhaler. The DPI would be marketed as Breo Ellipta for the treatment of COPD. Background materials will be available on this web page prior to the meeting, according to the FDA.
The deadline for requests to speak at the meeting is April 1. Written submissions should be provided to the FDA by April 9, 2013. Anyone who requested time to speak at the March 7 meeting must make another request for the April 17 meeting.
Read the meeting notice.
