FDA approves expanded uses of Merck med
Merck today announced that the U.S. Food and Drug Administration (FDA) has approved two supplemental new drug applications (sNDA's) for SAPHRIS® (asenapine) sublingual tablets to expand the product's indications. SAPHRIS is now indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. SAPHRIS was initially approved in the United States on August 13, 2009 for the acute treatment of schizophrenia in adults and as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.
“These FDA approvals demonstrate our active commitment to further understand how our medicines can be used to help physicians help their patients, and we look forward to discussing these new uses for SAPHRIS with the mental health community,” said David Michelson, M.D., vice president of Neuroscience Clinical Research, Merck.
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