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FDA accepts regulatory filing for Depomed drug

Drug maker seeks approval for Serada for menopausal hot flashes

MENLO PARK, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.

Depomed submitted its application to the FDA for Serada (gabapentin), an extended-release drug for hot flashes in menopausal women.

The FDA's Reproductive Health Drugs Advisory Committee will discuss the drug at a meeting scheduled for March 2013. Advisory committees, which consist of experts convened by the FDA, issue recommendations of whether the agency should approve drugs. Their recommendations are not binding, but the agency usually follows them. The FDA is expected to decide whether or not to approve the drug in May 2013.


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