MAP Pharmaceuticals has resubmitted its New Drug Application (NDA) for Levadex inhaled dihydroergotamine for the treatment of migraine to the FDA, the company has announced. The FDA issued a complete response letter to MAP in March, 2012 and a form 483 to its contract manufacturer.
MAP President and CEO Timothy S. Nelson said, “We have worked diligently on our Levadex resubmission and, based on our dialogue with the FDA, we believe that we have addressed the issues outlined by the FDA in the Complete Response letter we received in March 2012. We continue to dedicate ourselves to making this potential new treatment for migraine sufferers available to many of the millions of patients whose migraines are not well treated with the options available today.”
Read the MAP press release.
