IndiplonTreatment for Insomnia
Indiplon IR NDA (New Drug Application) to Be Reformatted Due to Difficulties in Accessing Portions of the Electronic NDA
SAN DIEGO, Dec. 21, 2004 -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced today that the U.S. Food and Drug Administration (FDA) has not accepted the Company's NDA for indiplon immediate release (IR) due to difficulties encountered in navigating the electronic NDA. Neurocrine is working to resolve the issues relating to the navigation of the electronic filing and to minimize any impact on the expected timelines for approval and launch of indiplon. The indiplon modified release (MR) filing is currently under review with the FDA and the Company is also working to address any potential formatting issues with the MR filing. The formatting issues are based solely on technical difficulties with the electronic navigation and do not pertain to the content of the filings.
The IR NDA was submitted on October 19, 2004 to the Anesthesia and Critical Care Division of the FDA and was transferred for review to the Neuropharm Division of the FDA on November 19, 2004. The Neuropharm Division is now responsible for the indiplon review and approval process. The filing contains studies which comprise one of the most extensive programs conducted to date in insomnia, with data from 68 clinical trials and over 80 preclinical studies. The NDA was filed in eCTD electronic format, which contains over 1,350 volumes or 475,000 pages of data.
Conference Call and Web Cast Today: December 21, 2004, 2004
Neurocrine will host a live conference call and web cast today, December 21, 2004 at 9:00 AM Eastern Standard Time (6:00 AM Pacific Standard Time). Participants may access the live conference call by dialing 1-800-540-0559 (U.S.) or 785-832-2422 (International) and using the identification code: NBIX. The call can also be accessed via the web cast through the Company's website at www.neurocrine.com. A replay of the conference call will be available approximately one hour after the conclusion of the call by dialing 1-877-856-8966 (U.S.) or 402-220-1610 (International). The call will be archived until January 4, 2005.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at www.neurocrine.com.
Posted: December 2004
- Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA - December 13, 2007
- Neurocrine Announces PDUFA Action Date of December 12, 2007 for Indiplon Capsules - August 22, 2007
- Neurocrine Announces Resubmission of New Drug Application for Indiplon Capsules - June 13, 2007
- Neurocrine Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA - September 5, 2006
- Neurocrine Completes Review of Indiplon Action Letters - June 15, 2006
- Neurocrine Receives Approvable Letter for indiplon Capsules and Non-Approvable for indiplon Tablets for the Treatment of Insomnia - May 16, 2006
- Neurocrine Announces Acceptance of New Drug Application for Indiplon Tablets - July 26, 2005
- Neurocrine Announces Acceptance of New Drug Application for Indiplon Capsules - June 14, 2005
- Neurocrine Announces Submission of New Drug Application for Indiplon Tablets - May 26, 2005
- Neurocrine Announces Submission of New Drug Application for Indiplon Capsules - April 14, 2005
- Neurocrine Biosciences Announces Resubmission Status of Indiplon - February 7, 2005
- Neurocrine Biosciences Announces Plans to Resubmit Indiplon Modified Release New Drug Application (NDA) - January 11, 2005
- Neurocrine Submits New Drug Application (NDA) for Indiplon Modified Release Tablets for the Treatment of Insomnia - November 22, 2004
- Neurocrine Submits New Drug Application (NDA) for Indiplon Immediate Release Capsules for the Treatment of Insomnia - October 19, 2004