Indiplon Approval Status

  • FDA approved: No
  • Brand name: Indiplon
  • Generic name: NBI-34060
  • Company: Neurocrine Biosciences, Inc.
  • Treatment for: Insomnia

Indiplon is a unique non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Indiplon was developed to address different types of sleep problems and is now in the FDA review process.

FDA Approval Status 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

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