FDA Approves First Generics for the Treatment of ADHD, BED

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The US Food & Drug Administration (FDA) announced that it has approved several generics for the treatment of attention-deficit/hyperactivity disorder (ADHD) and binge-eating disorder (BED).

The first generics of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets are now approved for the treatment of ADHD in patients aged 6 years and older and for the treatment of moderate to severe BED in adults.¹ These approvals follow the FDA’s announcement of the shortage of an immediate-release formulation of amphetamine mixed salts (Adderall) on October 12, 2022.²

“The shortages of stimulants (largely generics) have been a nightmare to children, families, and their practitioners,” Timothy Wilens, MD, chief of the Division of Child and Adolescent Psychiatry and codirector of the Center for Addiction Medicine at Massachusetts General Hospital, told Psychiatric Times®. “At a public health level, it is important for policy makers to understand their multifaceted nature and work together to help alleviate such severe, impactful shortages in the future.”²

With the approval of the lisdexamfetamine dimesylate generic for the treatment of ADHD, more patients with ADHD may have access to treatment. In addition to approving generics, the FDA has announced that it will continue to address the ongoing Adderall shortage by providing assistance to manufacturers, monitoring supply, and sharing updates and other information about the shortage.³

References

1. FDA approves multiple generics of ADHD and BED treatment. US Food & Drug Administration. News release. August 28, 2023. Accessed August 29, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-multiple-generics-adhd-and-bed-treatment?utm_medium=email&utm_source=govdelivery

2. Kunz L. The Rx crisis: the impact of ongoing ADHD medication shortages. Psychiatric Times. August 7, 2023. Accessed August 29, 2023. https://www.psychiatrictimes.com/view/the-rx-crisis-the-impact-of-ongoing-adhd

3. FDA announces shortage of Adderall. US Food & Drug Administration. Updated August 1, 2023. Accessed August 29, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-shortage-adderall