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