Allergan announced that the FDA has issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for Levadex (dihydroergotamine) inhalation aerosol for the acute treatment of migraines in adults. The NDA was previously submitted in May of 2011. In addition to the CRL, the company has also already received draft labeling from the FDA. Allergan anticipates minimal revisions to this labeling.
Levadex is an orally inhaled formulation of dihydroergotamine (DHE) using MAP Pharmaceuticals’ proprietary TEMPO inhaler.
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