The US Food and Drug Administration (FDA) has accepted MAP Pharmaceuticals' New Drug Application (NDA) resubmission for Levadex, an orally inhaled migraine drug for the potential acute treatment of migraine in adults. The FDA has classified the resubmission as a complete, Class 2 response to the FDA's March 26, 2012 action letter and has set a goal date of April 15, 2013 under the Prescription Drug User Fee Act.
"The acceptance of our Levadex resubmission is an important milestone for the company," said Timothy S Nelson, president and chief executive officer of MAP Pharmaceuticals. "We will continue to work closely with the FDA through the review process, with the goal of providing the underserved migraine patient population with a potential new treatment option in 2013."
MAP Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing new therapies to address undermet patient needs in neurology.