Indiplon FDA Approval Status
FDA Approved: No
Brand name: Indiplon
Generic name: NBI-34060
Company: Neurocrine Biosciences, Inc.
Treatment for: Insomnia
Indiplon is a novel pyrazolopyrimidine sedative-hypnotic agent intended for use in the treatment of insomnia.
In December 2007, Neurocrine Biosciences, Inc. announced the receipt of an Approvable Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Indiplon was approvable pending additional clinical and preclinical data. Neurocrine has since decided to discontinue all clinical and marketing development of Indiplon in the United States.
Development timeline for Indiplon
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
