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The meeting of the Anti-Infective Drugs Advisory Committee scheduled for February 27, 2008, is cancelled. This meeting was announced in the Federal Register of January 11, 2008 (73 FR pages 2055, 2056).
The Feb. 27, 2008, Anti-Infective Drugs Advisory Committee meeting to discuss Theravance, Inc.'s New Drug Application (NDA) 22-110 for telavancin for the treatment of complicated skin and skin structure infections has been cancelled to allow time for the FDA to review and resolve several outstanding issues. The agency intends to continue evaluating NDA 22-110 and will schedule an Advisory Committee meeting in the future, as needed.
CONTACT:
Sohail Mosaddegh, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane 301-827-7001, e-mail: sohail.mosaddegh@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443- 0572 in the Washington, DC area), code 3014512530.