Biotech Values

[Biowatch]

Neurocrine says FDA seeks more details on sleep drug
Tue Sep 5, 2006 7:34 AM ET

Sept 5 (Reuters) - Neurocrine Biosciences Inc. (NBIX.O: Quote, Profile, Research) on Tuesday said U.S. regulators have asked for additional details related to its insomnia drug indiplon. The biopharmaceutical company said in an end-of-review meeting, the Food and Drug Administration requested the company to supplement the pharmacokinetic and food effect profile of indiplon capsules to include several meal types.

Neurocrine said it expects to re-submit the drug for marketing approval with the FDA before the end of the second quarter of 2007. (Reporting by Ankur Relia in Bangalore)