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Please note that the Briefing Material below may include references to the originally scheduled Pulmonary-Allergy Drugs Advisory Committee meeting which was to take place on March 7, 2013. This originally scheduled meeting was postponed and rescheduled for April 17, 2013 due to unanticipated weather conditions.
Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. § 552).
FDA Briefing Information for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PDF – 4.18MB)
Errata to the FDA Briefing Information for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PDF – 78KB)
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.