The U.S. Food and Drug Administration (FDA) has approved the first generics of Vyvanse for attention deficit hyperactivity disorder (ADHD) to address the ongoing shortage of ADHD medicine in the United States.
The FDA said on Aug. 28 that it had approved several generics of Takeda Pharmaceutical’s drug Vyvanse for people aged 6 years and older with ADHD and 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,” it said in a statement.
Drugmakers have begun shipping copycat versions of Vyvanse following FDA approval, which come in both capsules and chewable tablets, with dosages ranging between 10 to 70 milligrams.
These pharmaceutical companies include U.S.-based drugmakers Mallinckrodt and Viatris, United Kingdom-based Hikma Pharmaceuticals, and Indian drugmaker Sun Pharmaceutical.
The generic drugmakers said they are working with the Drug Enforcement Administration (DEA) as the drugs are classified as a controlled substance.
Takeda has announced on its website that it was experiencing a low inventory of 40 milligrams, 60 milligrams, and 70 milligrams of Vyvanese capsules, citing 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,” it stated.
“It is possible that an increased demand on other dosage strengths of Vyvanse may occur, resulting in localized shortages of these other strengths,” the pharmaceutical company added.
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 warned of an ongoing shortage of amphetamine mixed salts, also referred to as Adderall, since last year after Teva Pharmaceutical reported experiencing intermittent manufacturing delays.
“Other manufacturers continue to produce amphetamine mixed salts, but there is not sufficient supply to continue to meet U.S. market demand through those producers,” the FDA stated.
The shortages occurred as more people started taking the ADHD medication. During the COVID-19 pandemic, prescriptions climbed as regulators started allowing doctors to prescribe the drug without first seeing a patient in person.
Prescriptions for Adderall and its generic equivalents jumped 20 percent between February 2020 and the end of last year, according to IQVIA. Adderall supplies face an additional challenge when demand spikes.
Federal regulators limit supplies for the drug each year because it is a controlled substance—medications that can cause physical and mental dependence—and have restrictions on how the prescriptions can be refilled.
Lauren Hoffman, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, told Everyday Health that the medication shortage could persist even with the availability of generic Vyvanse.
“It’s quite possible that we may see shortages even of these new products as manufacturers work to ramp up production and meet demand,” Ms. Hoffman told the outlet on Aug. 31.
Reuters and the Associated Press contributed to this report.