U.S. boosts production limits for ADHD drug amid shortages
- The DEA has increased the production limit for Vyvanse and its generics by about 24% to combat ongoing shortages.
- This increase follows a request from the FDA in July and is a response to years of supply issues exacerbated by manufacturing delays from other ADHD drugmakers.
- The adjustments are crucial to ensure a stable supply of lisdexamfetamine for patients in the U.S. and globally.
The Drug Enforcement Administration (DEA) has announced an increase in the production limit for Vyvanse, an ADHD medication produced by Takeda Pharmaceutical, along with its generic versions. This decision, which raises the production limit by approximately 24%, aims to alleviate the ongoing shortages of the drug in the United States. The FDA had previously requested this increase in July, highlighting the urgent need to address the supply issues that have persisted for years. The shortage of ADHD medications has been exacerbated by manufacturing delays faced by Teva Pharmaceutical Industries, particularly with their Adderall product, which was reported in October 2022. This situation led to a surge in demand for Vyvanse, further straining its availability. The DEA's adjustment includes an additional 1,558 kilograms to meet rising domestic demand and 4,678 kilograms to cater to increased foreign demand for finished dosage forms. Vyvanse, known chemically as lisdexamfetamine, is classified as a schedule II controlled substance due to its potential for abuse, necessitating strict prescribing regulations. The increase in production limits is seen as a critical step to ensure that patients in the U.S. and abroad have access to this essential medication without interruption. The FDA's approval of generic versions of Vyvanse from multiple manufacturers, including Mallinckrodt and Viatris, last year has also contributed to the efforts to stabilize the supply chain. The DEA's proactive measures are intended to secure an adequate supply of lisdexamfetamine, addressing both domestic and global patient needs effectively.