The drug was developed by Schering-Plough and competes with drugs in the already crowded filed of anti-psychotic drugs already on the market. Merck purchased Schering Plough last year. BD
TRENTON, N.J. -- Merck & Co. said Tuesday its schizophrenia drug
Saphris has been approved for two additional uses by the Food and Drug Administration.
The drug was first approved in August 2009 for treating acute schizophrenia episodes in adults and acute mania or manic-depressive behavior in adults with bipolar disorder.
Merck says the FDA now has approved Saphris for ongoing treatment of schizophrenia and for treating acute mania or manic-depressive behavior in adult bipolar patients along with lithium, a mood-stabilizing drug often used to treat mania, or the ant seizure drug valproate.
Saphris carries the FDA's strongest caution, a black box warning, that it nearly doubles risk of death in elderly patients with dementia.
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