Amid Shortages, U.S. Allows Expanded Production of ADHD Drug Vyvanse
By Robin Foster HealthDay Reporter
THURSDAY, Sept. 5, 2024 -- The maker of the ADHD drug Vyvanse has been given approval by the U.S. Drug Enforcement Administration to make more of the medication as a shortage of the critical drugs continues.
Following a request from the U.S. Food and Drug Administration in July, the DEA said Thursday that Takeda Pharmaceuticals may now increase its production limit by 24%.
“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine [Vyvanse] to meet legitimate patient needs both domestically and globally,” the DEA said in a notice it posted on the approval.
ADHD drugs have been in short supply for years. The FDA first warned of a shortage of Teva Pharmaceutical Industries’ Adderall medication in October 2022, as the company was plagued by manufacturing delays.
That prompted a spike in demand and subsequent shortage of Takeda’s Vyvanse.
Why was the DEA's approval to boost production needed? Vyvanse (lisdexamfetamine) is classified by the DEA as a schedule II controlled substance, which is applied to drugs considered to have a high likelihood of being abused, so additional prescribing safeguards are put in place.
The production limit for lisdexamfetamine was increased by 13, 478 pounds (6,236 kilograms), which includes 3,434 pounds (1,558 kg) to address domestic demand and 10,313 pounds (4,678 kg) for foreign demand for finished dosage medications, according to the DEA.
After Takeda lost exclusivity of Vyvanse last year, the FDA approved generic versions of Vyvanse from 11 drugmakers, including U.S.-based drugmakers Mallinckrodt and Viatris, UK-based Hikma Pharmaceuticals and Indian drugmaker Sun Pharmaceutical Industries, Reuters reported.
Sources
- U.S. Drug Enforcement Administration, notice, Sept. 4, 2024
- Reuters
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted September 2024
Read this next
FDA Will Now Require Labeling of ADHD Medication to Indicate Weight Loss Risk
WEDNESDAY, July 2, 2025 -- The U.S. Food and Drug Administration is revising the labeling of all extended-release attention-deficit/hyperactivity disorder (ADHD) medications...
ADHD Stimulants Can Be Safely Prescribed Via Telehealth, Study Argues
MONDAY, June 16, 2025 — People with ADHD might be prescribed their meds remotely without increasing their risk of addiction, a new study says. Experts have worried that...
Screen Time And Troubled Kids: Is There A Vicious Circle?
THURSDAY, June 12, 2025 — A “vicious circle” might exist between screen time and troubled children, a new evidence review says. Screen time — particularly...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.