MAP Pharmaceuticals has announced that it has a meeting scheduled with the FDA during the second quarter of this year to discuss the complete response letter it received for its Levadex inhaled dihydroergotamine application. MAP President and CEO Timothy S. Nelson said, “We are pleased that the FDA has scheduled a meeting with us to discuss the issues contained in the Complete Response letter for Levadex. We continue to work closely together with our partner, Allergan, as we seek to resolve the issues in the Complete Response Letter as quickly as possible.”
The company also announced that the United States Patent and Trademark Office (USPTO) issued US Patent No. 8,148,377, titled “Method of Therapeutic Administration of DHE to Enable Rapid Relief of Migraine While Minimizing Side Effect Profile” to the company on April 3, 2012. The new patent is MAP’s third related to Levadex’s pharmacokinetics.
Read the MAP Pharmaceuticals press release.