FDA approves first generic versions of Vyvanse to address ADHD medicine shortage.
The U.S. Food and Drug Administration (FDA) has exciting news for those affected by attention deficit hyperactivity disorder (ADHD). They have recently approved the first generics of Vyvanse, a medication used to treat ADHD, in order to address the ongoing shortage of this much-needed medicine in the United States.
The FDA made the announcement on Aug. 28, stating that they have approved several generics of Takeda Pharmaceutical’s drug Vyvanse. These generics are now available for individuals aged 6 years and older with ADHD, as well as for adults with moderate and severe binge-eating disorder.
“FDA-approved generic medicines work in the same way and provide the same clinical benefit and risks as their brand-name counterparts,” the FDA stated in a press release.
Following FDA approval, various pharmaceutical companies, including Mallinckrodt and Viatris in the U.S., Hikma Pharmaceuticals in the United Kingdom, and Sun Pharmaceutical in India, have started shipping copycat versions of Vyvanse. These generics come in both capsules and chewable tablets, with dosages ranging between 10 to 70 milligrams.
It’s important to note that these generic drugs are classified as controlled substances, and the generic drugmakers are working closely with the Drug Enforcement Administration (DEA) to ensure compliance.
Takeda Pharmaceutical, the manufacturer of Vyvanse, has acknowledged the shortage of their product on their website. They attribute the low inventory of 40 milligrams, 60 milligrams, and 70 milligrams of Vyvanse capsules to a manufacturing delay compounded by increased demand.
“Supply of the 40mg strength will dip in mid-June and will be replenished in a few weeks. The impact to the 60mg and 70mg strengths is expected to begin in late June or early July and continue into September,” Takeda stated.
They also added, “It is possible that an increased demand on other dosage strengths of Vyvanse may occur, resulting in localized shortages of these other strengths.”
Research has linked magnesium deficiency with attention deficit hyperactivity disorder. (Santi Vedrí/Unsplash)
Ongoing Shortage of ADHD Medication
ADHD is a neurodevelopmental disorder that is usually first diagnosed in childhood and can last into adulthood. People with ADHD may have trouble paying attention, controlling impulsive behaviors, or being overtly active, according to the FDA.
The FDA has been warning about the ongoing shortage of amphetamine mixed salts, commonly known as Adderall, since last year. This shortage was initially reported by Teva Pharmaceutical, who experienced intermittent manufacturing delays.
“Other manufacturers continue to produce amphetamine mixed salts, but there are supply constraints,” the FDA stated.
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