March 31, 2014 8:00 a.m. to 5:00 p.m.: Anti-Infective Drugs Advisory Committee Meeting.
March 31, 2014 8:00 a.m. to 5:00 p.m.: Anti-Infective Drugs Advisory Committee Meeting
Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.
You can access the current roster of the Anti-Infective Drugs Advisory Committee HERE.
During the morning session on March 31st, the committee will discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, submitted by Trius Therapeutics, respectively, for the proposed indication of treatment of acute bacterial skin and skin structure infections.
During the afternoon session on March 31st, the committee will discuss NDA 021-883, dalbavancin hydrochloride for intravenous injection, submitted by Durata Therapeutics International B.V., for the proposed indication of treatment of acute bacterial skin and skin structure infections.
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