NDA Accepted for Serada for Menopausal Hot Flashes
Depomed announced that its New Drug Application (NDA) for Serada has been accepted for filing by the FDA, seeking approval for the treatment of menopausal hot flashes.
The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 31, 2013. The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
Serada is a proprietary extended-release formulation of gabapentin. Scientists hypothesize that gabapentin may reduce hot flashes by regulating the flow of calcium in and out of cells, which is one mechanism for controlling body temperature.
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