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www.fdanews.com/articles/72856-neurocrine-submits-new-drug-application-for-indiplon-tablets

Neurocrine Submits New Drug Application for Indiplon Tablets

May 31, 2005

Neurocrine Biosciences has completed submission of a new drug application (NDA) to the FDA for indiplon tablets for the treatment of insomnia in both adult and elderly patients.

The NDA for indiplon capsules was submitted to the FDA in April of 2005. These filings are based on clinical data supporting that both indiplon capsules and tablets show significant improvement in all sleep onset, sleep maintenance and sleep quality parameters.