No pharmacy in the United States can fill a Simtriyo prescription yet, and the reason has nothing to do with manufacturing or insurance. The Drug Enforcement Administration has not yet decided how tightly the drug will be controlled.
Otsuka's newly approved ADHD capsule is classified in its own label as a central nervous system stimulant, and federal law requires the DEA to assign a controlled substance schedule before a stimulant can be dispensed. That review is a standard step for all newly approved CNS stimulants and can take up to three months. Otsuka has said only that it expects the drug to be available later this year.
