FDA
24th February 2014

Meeting Announcement – AFREZZA

During this meeting, the committee will discuss new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation.

Meeting Announcement – AFREZZA


April 1, 2014 8:00 a.m. to 5:00 p.m.: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement 

Where:

The Marriott Inn and Conference Center
University of Maryland University
College (UMUC), Potomac Ballroom
3501 University Blvd. East
Hyattsville, Maryland

During this meeting, the committee will discuss new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation. The proposed indication (use) for this application is to improve glycemic control in adult patients with type 1 or type 2 diabetes mellitus.

Please click HERE for the current roster of the Endocrinologic and Metabolic Drugs Advisory Committee.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

Do you want to find out what happens during this drug’s FDA AdComm meeting? Great news – ISS can help you! Click on the link below in order to receive a summary of this meeting’s outcome!

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