FDA approves multiple lisdexamfetamine dimesylate generics for ADHD in children

FDA approves multiple lisdexamfetamine dimesylate generics for ADHD in children | Image Credit: © Stepan Popov- © Stepan Popov - stock.adobe.com.

The FDA has approved multiple first generics of lisdexamfetamine dimesylate (Vyvanse; Takeda Pharmaceuticals USA Inc) chewable tablets and capsules for patients 6 years and up with attention-deficit/hyperactivity disorder (ADHD), the federal agency announced in a press release on August 28, 2023.

Generic medicines approved by the FDA function in the same manner as the brand-name counterparts. A boxed warning informing health care providers about potential risk of dependence and abuse is listed for lisdexamfetamine dimesylate chewable tablets and capsules. Drugs containing amphetamines and methylphenidate, including lisdexamfetamine dimesylate, have a high potential for abuse, the FDA states. These drugs increase certain brain chemical levels, which can lead to addiction and overdose.

Warnings and precautions for serious cardiovascular reactions, blood pressure and heart rate increases, psychiatric adverse reactions, suppression of growth, peripheral vasculopathy, and serotonin syndrome (overage of serotonin that could be life-threatening) are also included in prescribing information for lisdexamfetamine dimesylate. See full prescribing information here.

According to the FDA, many abbreviated new drug applications (ANDAs) for lisdexamfetamine dimesylate received priority review. In children, adolescents, and adults with ADHD, the most common side effects for lisdexamfetamine dimesylate chewable tablets and capsules were anxiety, anorexia, decreased appetite, decreased weight, dry mouth, dizziness, insomnia, irritability, nausea, upper abdominal pain, and vomiting.

Patients with ADHD can have trouble with attention, controlling impulsive behaviors, and can be “overly” active, the FDA states. One of the most common neurodevelopmental disorders in childhood, ADHD affects approximately 10% of children. The disorder is typically diagnosed in childhood and can last into adulthood. It can be managed with “behavioral and pharmacological treatment, and some symptoms may improve as the child ages.”

In addition to approving these generics for children, adolescents and adults with ADHD, the generic chewable tablets and capsules are also approved for adults with moderate to severe binge-eating disorder (BED), as the most common side effects in this patient population were dry mouth, insomnia, decreased appetite, increased heart rate, feeling jittery, constipation, and anxiety.

Reference:

FDA approves multiple generics of ADHD and BED treatment. FDA. Press 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