Generic Versions of ADHD Drug Vyvanse Approved by FDA

The Food and Drug Administration (FDA) has granted approval for the first generic versions of Vyvanse, a medication used to treat attention deficit/hyperactivity disorder (ADHD). This decision comes at a critical time when there is a shortage of ADHD treatment drugs across the country.

According to the FDA’s announcement, the newly approved generic medication is effective in treating both ADHD in patients aged six and older, as well as binge-eating disorder in adults.

The FDA assures that the generic versions of Vyvanse work in the same way and offer the same benefits and risks as their brand-name counterparts.

This approval has come amidst a nationwide shortage of Adderall, a commonly prescribed drug for ADHD treatment. The FDA first alerted the public about this shortage in October, citing insufficient supply to meet the increasing demand for the medication. As the school year begins, millions of children diagnosed with ADHD are returning to classrooms, highlighting the urgent need for medication that helps them stay focused.

According to data from the Centers for Disease Control and Prevention (CDC), as of 2016, just over 62 percent of children aged 2 to 17 with ADHD were taking medication for their condition. This represents 1 in 20 U.S. children.

The shortage can be attributed to unexpected spikes in demand, manufacturing issues, and limited supplies of ingredients. An analysis conducted by the CDC earlier this year revealed a surge in prescriptions for ADHD treatment during the COVID-19 pandemic, primarily due to expanded access to drugs through telehealth services.

Due to ADHD medications being classified as controlled substances, the FDA and the U.S. Drug Enforcement Administration (DEA) impose limitations on the annual production of these medicines. This has led to calls for increasing the annual threshold to address the supply shortages.

In a letter released earlier this month, the FDA and the DEA expressed their collaboration with manufacturers, agencies, and stakeholders in the supply chain to understand, prevent, and mitigate the impact of these shortages.

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