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FDA Panel Recommends Against Approval of Drugs to Treat Hot Flashes

by Kathy Jones on March 5, 2013 at 9:11 PM
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 FDA Panel Recommends Against Approval of Drugs to Treat Hot Flashes

The US Food and Drug Administration has been advised to reject Noven Pharmaceuticals' drug for treating hot flashes in menopausal women.

An advisory panel to the agency voted 10-4 against approval of the drug with many of the members saying that the benefits of the drug were not enough to outweigh the risks. The panel also voted 12-2 against approving another drug, Depomed's Sefelsa, for similar reasons and added that three clinical trials did not show any marked reduction in hot flashes in menopausal women.

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Depomed's chief executive, Jim Schoeneck said that his company will stop spending on Sefelsa unless the hurdles for approving similar drugs are not overcome. "Based on today's meeting we believe the hurdles for approval of a nonhormonal treatment for hot flashes remain high. Until we believe there is a positive direction for Sefelsa, we will cease all spending relating to the product candidate", he said.



Source: Medindia
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