Neurocrine Receives Approvable Letter For Indiplon Capsules With Additional Safety And Efficacy Data Required By FDA

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced that the Company has received communication from the U.S. Food and Drug Administration (FDA) indicating that the New Drug Application (NDA) for indiplon 5 mg and 10 mg capsules for the treatment of insomnia is approvable pending additional clinical and preclinical data. [click link for full article]

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Filed under: Sleep / Sleep Disorders on December 15th, 2007