FDA Accepts Filing of NDA Resubmission for Levadex
MAP Pharmaceuticals announced that its New Drug Application (NDA) resubmission for Levadex for the potential acute treatment of migraine in adults has been accepted for filing by the FDA. Levadex is an orally inhaled formulation of dihydroergotamine.
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.
For more information call (650) 386-3100 or visit www.mappharma.com.