NEW DRUG APPLICATION SUBMITTED FOR SERDOLECT
Copenhagen, Denmark, Sept. 15 2008-H. Lundbeck AVS announced today that the U.S. Food and Drug Administration (FDA) has completed the initial check for completeness and accept the New Drug Application for Serdolect for the treatment of Schizophrenia for review.
ABOUT SERDOLECT
Serdolect is an effective antipsychotic drug for the treatment of Schizophrenia without sedative effect and with plecebo levelextapyramidal symptoms (EPS), the lack of sedative and anticholinergic effects to benefit cognition, which often is impaired in patients suffering from Schizophrenia.
The efficacy, tolerability, and safety of Serdolect has through daily clinical practice been confirmed in more than 70,000 patients. Serdolect's clinical and pharmacological profile indicates that the drug may improve their daily functioning and their quality of life and reduce the risk of relapse.
Serdolect derives from Lunbeck's in-house research and the company holds the global rights.
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