Noven Pharmaceuticals, a wholly-owned subsidiary of Japanese drugmaker Hisamitsu Pharmaceutical, has received US Food and Drug Administration approval for its New Drug Application (NDA) for Secuado (asenapine maleate) transdermal system for the treatment of schizophrenia.
This product is the first transdermal patch formulation for schizophrenia to be approved in the USA, with the NDA having been supported by Phase III data.
Secuado carries a boxed warning for increased risk of death in elderly patients with dementia-related psychosis.
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