The U.S. drug administrator has allowed an increased Vyvanse production of around 24 percent to help with the ADHD drug shortage nationwide.
The Drug Enforcement Administration (DEA) greenlighted the spike in production following the Food and Drug Administration (FDA) request, according to a notice first reported by Bloomberg News. FDA’s request came in July.
To deal with the ongoing drug shortage, which has continued for some time, the DEA granted the elevation of the production limit for the ADHD drug made by Takeda Pharmaceutical Co. and its rivals.
The FDA warned about a shortage of Adderall in 2022. The drug is often prescribed for ADHD and narcolepsy. At the time, Teva Pharmaceuticals, the largest supplier of the drug in the U.S., was dealing with supply disruptions. The lack of availability eventually led to a shortage of Vyvanse, also known as lisdexamfetamine.
Lisdexamfetamine is classified as a Schedule II controlled substance by the DEA since it can be addictive and has a high probability of being abused.
“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” the DEA said in the notice, adding that the production limit for lisdexamfetamine rose by 6,236 kilograms.
Of the total amount, 4,678 kg was for increased foreign demand and 1,558 kg for domestic.
“Extrapolation utilizing previous years’ reported data suggests the export requirements for lisdexamfetamine active pharmaceutical ingredient and finished dosages likely will continue to increase in 2024 and beyond,” the DEA said. “An increase in domestic manufacturing of the active pharmaceutical ingredient and finished dosages is necessary to supply lisdexamfetamine products to foreign markets.”
