Approvals
FDA approves new Vyvanse generics for ADHD and BED treatment amid ongoing shortages
The US Food and Drug Administration (FDA) has announced that it has approved several first generics of Takeda’s Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets for attention-deficit/ hyperactivity disorder (ADHD) in patients over the age of six years and for moderate-to-severe binge-eating disorder (BED) in adult patients.
It is hoped that the approval of these generics will help to reduce the burden of the ongoing shortage of Vyvanse, with a note on the Vyvanse website warning that it was ‘currently experiencing low inventory of Vyvanse capsules due to a manufacturing delay compounded by increasing demand.’
Dosing details for the generics remain consistent with Vyvanse, with the generic medicines working in the same way and providing the same clinical benefit and risks as the brand-name counterpart.
According to the FDA’s press release, the most common side effects in children, adolescents and adults with ADHD taking this medication were: ‘anorexia, anxiety, decreased appetite, decreased weight, diarrhoea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain and vomiting.’ While the most common side effects in adults with BED were: ‘dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery and anxiety.’
The generics will also come with a boxed warning ‘to inform healthcare providers and patients about the potential risk of abuse and dependence,’ due to the potential risk of addiction and overdose of these medications.
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