FDA Requests Study for Neurocrine's Drug
Posted on: Tuesday, 5 September 2006, 12:01 CDT
Neurocrine said Tuesday the U.S. Food and Drug Administration wants another study before it can approve insomnia treatment indiplon.
The FDA had previously issued an approvable letter for indiplon.
Neurocrine recently had an end-of-review meeting with the agency about indiplon and said the FDA requested a study to supplement the pharmacokinetic/food effect profile of the drug to include several meal types.
Neurocrine said it would initiate the study shortly after consultation with the agency. The company said the FDA did not require any other clinical trials.
Subject to those further consultations with the FDA we are expecting to provide a complete re-submission sometime before the end of the second quarter 2007, said Gary Lyons, Neurocrine's president and chief executive officer.
Neurocrine said its resubmission will also include additional analyses and modifications of previous analyses to address questions raised by the agency.
The company said another meeting with the FDA to discuss and clarify action items for indiplon is scheduled for late October 2006.
Source: United Press International
Related Articles
- FDA to Study Images' Impact in Drug Ads
- Positive Results for Neurocrine Endometriosis Drug Study
- Neurocrine: FDA Raised Questions About Drug
- Quigley Pharma Issued An Investigational New Animal Drug (INAD) Number By The FDA To Study Its Anti-Viral Compound For Avian Flu In Pigs; Pigs May Serve As Intermediate Hosts for Virus & Source of Transmission to Humans
- Quigley Pharma is Issued Three Investigational New Animal Drug (INAD) Numbers By the FDA To Study Its Anti-Viral Compound On Avian Flu
- InSightec Announces Enrollment of African American Women in FDA PostMarketing Study
- FDA Official Defends Agency's Safety Role
- FDA to Study Adult Antidepressant Effects
- FDA Halts Study on Dietary Supplements
 |
 |
User Comments (0)
RSS Feeds