The FDA has issued a complete response letter to MAP Pharmaceuticals’ NDA for Levadex dihydroergotamine inhalation aerosol for the treatment of migraine headaches. According to MAP, “the FDA requested that the Company address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The FDA also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA.” The company says that it will request a meeting with the agency to discuss its concerns.
Map says that the FDA did not request any additional studies or raise any safety or efficacy issues. In addition, the company says that it “is pleased with the FDA-provided revisions to product labeling and packaging, including correct use of the Levadex trade name.”
MAP Pharmaceuticals President and CEO Timothy S. Nelson commented, “MAP is committed to making this important new therapy available to people who experience migraine. We will continue to work closely with the FDA to finalize our product labeling and to address the issues raised in the Complete Response letter as quickly as possible.”
Read the MAP Pharmaceuticals press release.
