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Article: Sepracor Submits U.S. New Drug Application for ESTORRA(TM) Brand Eszopiclone for Treatment of Insomnia.
- Article from:
- PR Newswire
- Article date:
- February 3, 2003
CopyrightCOPYRIGHT 2003 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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Sepracor Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking clearance to market ESTORRA(TM) brand eszopiclone 2 mg and 3 mg tablets for the treatment of transient and chronic insomnia. ESTORRA was studied in the 3 mg dosage strength for adults and in the 2 mg dosage strength for treatment of the elderly population.
The NDA contains a total of 24 clinical trials, which included more than 2,700 adult and elderly subjects, and more than 60 preclinical studies. A total of six randomized, placebo-controlled Phase III studies, including one with a positive control, were conducted for the ...