The Food and Drug Administration (FDA) approved the first generic versions of Vyvanse, a drug used to treat attention deficit/hyperactivity disorder (ADHD), a decision that comes amid a nationwide shortage of ADHD treatment drugs.
The newly approved medication can treat both ADHD in patients six years and older and binge-eating disorder in adults, the FDA said in an announcement.
The FDA said the generic versions of Vyvanse “work in the same way” and have the same benefit and risks as their brand-name counterparts.
The approval comes amid the nationwide shortage of Adderall, a drug commonly prescribed to treat ADHD. The FDA first announced the shortage in October, citing an insufficient supply to meet the growing demand for the drug. Millions of children diagnosed with ADHD are returning to classrooms as the school year kicks off, highlighting the demand for medication that can help them stay focused.
According to data from the Centers for Disease Control and Prevention (CDC), just over 62 percent of children aged 2 to 17 with ADHD took medication for the condition as of 2016, representing 1 in 20 U.S. children.
Unexpected demand spikes, manufacturing problems and limited ingredient supplies have all contributed to the shortage. A CDC analysis earlier this year found prescriptions to treat ADHD surged during the COVID-19 pandemic, as access to drugs expanded with telehealth opportunities.
Because ADHD medications are considered controlled substances, the FDA and the U.S. Drug Enforcement Administration (DEA) place limits on how much medicine can be produced annually. This has sparked calls to raise the annual threshold.
A letter earlier this month from the FDA and the DEA said they are “working closely with numerous manufacturers, agencies and others in the supply chain to understand, prevent and reduce the impact of these shortages.”