MAP Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) of Levadex for the potential acute treatment of migraine in adults. The submission includes efficacy and safety data from the Phase 3 FREEDOM-301 clinical trial and the open-label, safety extension along with other pharmacokinetic and pharmacodynamic studies. The NDA has a goal date of March 26, 2012 under the Prescription Drug User Fee Act (PDUFA).
Levadex is an orally inhaled formulation of dihydroergotamine (DHE).
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