The U.S. Drug Enforcement Administration (DEA) has granted Takeda Pharmaceuticals approval to increase the production of Vyvanse (lisdexamfetamine) by 24%, addressing persistent shortages of ADHD medications. This decision comes after a request from the U.S. Food and Drug Administration (FDA) in July, aiming to stabilize the supply of this critical drug.
The DEA's approval allows Takeda to increase its production limit by 13,478 pounds (6236 kg), which includes 3434 pounds (1558 kg) to address domestic demand and 10,313 pounds (4678 kg) for foreign demand for finished dosage medications. This adjustment is intended to meet the legitimate needs of patients both in the United States and globally, according to the DEA.
Background of the Shortage
ADHD drugs have been in short supply for several years. The FDA first warned of an Adderall shortage in October 2022, when Teva Pharmaceutical Industries experienced manufacturing delays. This shortage prompted a spike in demand for Vyvanse, leading to subsequent supply issues.
DEA's Role and Classification of Vyvanse
Vyvanse (lisdexamfetamine) is classified by the DEA as a schedule II controlled substance due to its potential for abuse, necessitating additional prescribing safeguards. The DEA's approval to boost production is crucial in managing the availability of this medication.
Generic Competition
After Takeda lost exclusivity of Vyvanse last year, the FDA approved generic versions from 11 drugmakers, including Mallinckrodt, Viatris, Hikma Pharmaceuticals, and Sun Pharmaceutical Industries. This generic competition is expected to further alleviate the supply shortage.
