The U.S. Drug Enforcement Administration (DEA) has authorized a roughly 24 percent increase in production of Vyvanse to address a nationwide shortage of ADHD medications.
The DEA approved the surge in production at the request of the Food and Drug Administration (FDA). According to the notice First reported Bloomberg NewsThe FDA's request was issued in July.
To address drug shortages that have been ongoing for some time, the DEA has approved increased production limits on ADHD drugs made by Takeda Pharmaceutical and its rivals.
The FDA warned of a shortage of Adderall in 2022. The drug is often prescribed to treat ADHD and narcolepsy. At the time, Teva Pharmaceuticals, the largest U.S. supplier of the drug, was dealing with supply disruptions. The availability issues ultimately led to a shortage of Vyvanse, also known as lisdexamfetamine.
Lizdexamfetamine is classified by the DEA as a Schedule II controlled substance because of its addictive potential and high potential for abuse.
“These adjustments are necessary to ensure that the United States has a sufficient and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs at home and abroad,” the DEA said in the notice, adding that the lisdexamfetamine production limit had been increased by 6,236 kilograms.
Of this, the increase in overseas demand was 4,678 kg, and the increase in domestic demand was 1,558 kg.
“Based on estimates utilizing reported data from the past several years, export demand for lisdexamfetamine active ingredient and finished product is likely to continue to increase beyond 2024,” the DEA said. “Increased domestic manufacturing of active ingredient and finished product is necessary to supply foreign markets with lisdexamfetamine products.”
