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FDA approves expanded indications for Merck's Saphris antipsychotic
Tuesday, September 07 2010 | Comments
What's This?
The Food and Drug Administration approved two supplemental New Drug Applications for Merck & Co. Inc.'s atypical antipsychotic, Saphris (asenapine maleate), regarding the treatment of schizophrenia and bipolar I disorder.The sublingual tablets are now indicated for the treatment of schizophrenia in adults. When the drug was approved in August of last year, one of the indications covered the acute treatment of schizophrenia in adults.
For adults with manic or mixed episodes associated with bipolar I disorder, Saphris is now approved as adjunctive therapy with lithium or valproate sodium for acute treatment. The drug is already approved as monotherapy for acute treatment in this patient population.
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