Federal Register #DEA-1743

DEA places Simtriyo’s active ingredient centanafadine in Schedule III

The DEA action places centanafadine, the active ingredient in Simtriyo, under Schedule III controls; it does not announce a procurement. - Government agency: U.S. Department of Justice, Drug Enforcement Administration (DEA). - Product mentioned: Simtriyo (centanafadine) extended-release capsules, in 140 mg, 210 mg, and 280 mg strengths. FDA approval covers adults and pediatric patients aged 6 years and older who weigh at least 20 kg. - Regulatory requirements: Schedule III controls apply to centanafadine, including specified salts and isomers, covering activities such as registration, security, labeling, inventory, recordkeeping, prescriptions, manufacturing, distribution, import, and export. - OEM/vendor: No manufacturer, OEM, or vendor is identified in the provided information. - Procurement status: No products or services are being solicited for purchase, and no award or contract value is provided.

Description

The Drug Enforcement Administration is issuing an interim final rule placing centanafadine, including its salts and specified isomers, in Schedule III of the Controlled Substances Act. The rule follows FDA approval of Simtriyo (centanafadine) for treatment of ADHD in adults and pediatric patients aged 6 years and older who weigh at least 20 kg. It establishes applicable Schedule III regulatory controls for handling, registration, storage, labeling, inventory, records, prescriptions, manufacturing, distribution, importation, and exportation. Comments are due November 30, 2026.

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