Insomnia

New drug application accepted for insomnia treatment

Published in Medical Letter on the CDC and FDA, August 28th, 2005

Neurocrine Biosciences, Inc., (NBIX) announced that the U.S. Food and Drug Administration (FDA) has accepted the company's new drug application (NDA) for indiplon tablets for review for the treatment of insomnia in both adult and elderly patients.

"This is an exciting milestone for Neurocrine and represents the company's first completed NDA filing," said Gary A. Lyons, president and CEO of Neurocrine Biosciences. "Data from these two submissions is supported by one of the most comprehensive clinical trial programs in insomnia and demonstrates the long-term safety and efficacy profile of indiplon in helping patients with sleep onset and sleep maintenance...

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Source: Medical Letter on the CDC and FDA (2005-08-28)

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