The newly approved generic versions are expected to be less expensive than the brand-name drug and may help ease the Adderall shortage.
One alternative medication to Adderall is lisdexamfetamine dimesylate, known as Vyvanse. But Vyvanse can be expensive, and generic forms of the medication are not available.
However, on August 28, the FDA announced the approval of the first generic versions of Vyvanse to treat ADHD in people six years and older and adults with moderate to severe binge-eating disorder (BED).
The approvals followed the recent expiration of Takeda Pharmaceutical's patent on Vyvanse, which opened the door for other manufacturers to develop generic versions of the drug. FDA-approved generic drugs provide the same clinical benefits and risks as their brand-name counterparts.
Many abbreviated new drug applications (ANDAs) for lisdexamfetamine dimesylate received priority review status from the FDA to expedite the process. And according to FDA documents, several pharmaceutical companies received approval for the drug.
The hope is that the agency's approval of generic Vyvanse will help address the ADHD medication shortage. However, it's unclear when the medications will be available at pharmacies nationwide.
What is Vyvanse?
Vyvanse is a prescription stimulant medication commonly used to treat ADHD and binge eating disorder that works by influencing specific chemicals in the brain that contribute to hyperactivity and impulse control. Moreover, it may have a longer-lasting effect than other ADHD medications.
Common side effects of Vyvanse include decreased appetite, difficulty sleeping, increased heart rate or blood pressure, and nervousness. However, the drug can cause serious adverse effects such as severe heart problems, psychiatric symptoms, growth suppression in young people, and serotonin syndrome.
Because it is an amphetamine prodrug, the medication's prescribing information also warns about potential misuse and dependence.