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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

DateArticle
Dec 13, 2007Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA
Aug 22, 2007Neurocrine Announces PDUFA Action Date of December 12, 2007 for Indiplon Capsules
Jun 13, 2007Neurocrine Announces Resubmission of New Drug Application for Indiplon Capsules
Sep  5, 2006Neurocrine Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA
Jun 15, 2006Neurocrine Completes Review of Indiplon Action Letters
May 16, 2006Neurocrine Receives Approvable Letter for indiplon Capsules and Non-Approvable for indiplon Tablets for the Treatment of Insomnia
Jul 26, 2005Neurocrine Announces Acceptance of New Drug Application for Indiplon Tablets
Jun 14, 2005Neurocrine Announces Acceptance of New Drug Application for Indiplon Capsules
May 26, 2005Neurocrine Announces Submission of New Drug Application for Indiplon Tablets
Apr 14, 2005Neurocrine Announces Submission of New Drug Application for Indiplon Capsules
Feb  7, 2005Neurocrine Biosciences Announces Resubmission Status of Indiplon
Jan 11, 2005Neurocrine Biosciences Announces Plans to Resubmit Indiplon Modified Release New Drug Application (NDA)
Dec 21, 2004Indiplon IR NDA (New Drug Application) to Be Reformatted Due to Difficulties in Accessing Portions of the Electronic NDA
Nov 22, 2004Neurocrine Submits New Drug Application (NDA) for Indiplon Modified Release Tablets for the Treatment of Insomnia
Oct 19, 2004Neurocrine Submits New Drug Application (NDA) for Indiplon Immediate Release Capsules for the Treatment of Insomnia

Further information

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