FDA issues Complete Response letter to MAP's NDA for LEVADEX

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the United States Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for LEVADEX® (dihydroergotamine) inhalation aerosol.

In the Complete Response letter, 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 FDA did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval.  The Company is pleased with the FDA-provided revisions to product labeling and packaging, including correct use of the LEVADEX trade name. The Company continues to pursue approval of LEVADEX for the acute treatment of migraine in adults.

MAP Pharmaceuticals plans to request a meeting with the FDA to discuss the issues raised in the Complete Response letter.

"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," said Timothy S. Nelson, President and Chief Executive Officer of MAP Pharmaceuticals.