Asenapine Transdermal Patch

Form: Transdermal Patch

Strength: 3.8 mg/24 hr, 5.7 mg/24 hr, 7.6 mg/24 hr

Reference Brands: Secuado®(US)

Category: Antipsychotropic Drugs

The Asenapine transdermal patch is FDA-approved in the United States (brand name: Secuado) for the treatment of schizophrenia in adults. It is the first and only transdermal antipsychotic approved in the U.S. As of now, it is not approved in the European Union, and marketing would require a new MAA (Marketing Authorization Application) via national or centralized procedures. Regulatory requirements in the U.S. include GMP-compliant patch manufacturing, transdermal pharmacokinetics, adhesion and skin safety data, and documentation addressing risks like extrapyramidal symptoms and QT prolongation. U.S. labeling includes warnings for elderly dementia-related psychosis. To explore dossier-ready Asenapine transdermal patches and alternatives, visit Pharmatradz.com — your global B2B pharma sourcing hub.