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Article: Neurocrine Submits New Drug Application (NDA) for Indiplon Immediate Release Capsules for the Treatment of Insomnia.
- Article from:
- PR Newswire
- Article date:
- October 19, 2004
CopyrightCOPYRIGHT 2004 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Neurocrine Biosciences, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of indiplon immediate release capsules for the treatment of insomnia. The application contains safety and efficacy results from seven Phase III clinical trials with indiplon immediate release conducted in adult and elderly patients with transient and chronic insomnia. Neurocrine is developing two formulations of indiplon, an immediate release capsule and modified release tablet, for the treatment of multiple forms of insomnia. Neurocrine expects to submit a second NDA for indiplon modified release tablets in ...
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Article: Neurocrine Biosciences Announces Resubmission ...
PR Newswire;
February 7, 2005 ;
700+ words
...Neurocrine Biosciences announced today that it completed ... the resubmission of its indiplon immediate release and modified release New Drug Applications ... Lyons, President & CEO of Neurocrine Biosciences. "We will take advantage of the ...
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