hal-gatewood-_jbclosdsd4-unsplash

FDA approves new ADHD and BED generics

Betsy Goodfellow | September 1, 2023 | News story | Medical Communications BED, FDA, Pharmacy, generic medicines 

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.

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.”

Advertisement

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.

Betsy Goodfellow

Related Content

MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance

Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …

Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation

Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …

Johnson & Johnson submits robotic surgical system for De Novo classification

Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …

The Gateway to Local Adoption Series

Latest content