The US Food and Drug Administration (FDA) has approved Merck's two supplemental new drug applications (sNDA's) for Saphris (asenapine) sublingual tablets to expand the product's indications.
Saphris is prescribed 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, an antipsychotic medication which works by changing the actions of chemicals in the brain, has received approval in the US on 13 August 2009.
Merck Neuroscience Clinical Research vice president David Michelson said that they look forward to discussing those new uses for Saphris with the mental health community.
(Source: http://regulatoryaffairs.pharmaceutical-business-review.com)
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