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FDA Grants Approval for Generic Vyvanse to Address Shortfall of ADHD Medications

Monday, the Food and Drug Administration announced that it authorized generic brands of Vyvanse, a substitute to Adderall that is becoming increasingly popular.

Over one million Americans routinely take Vyvanse, which is frequently prescribed for both attention-deficit/hyperactivity disorder (ADHD) as well as binge eating disorder.

At present, a 30-day supply of the brand-name drug costs $369, which is more than three times the original price when Vyvanse was first introduced in 2007.

The decision made on Monday, however, will enable over a dozen companies to produce more affordable generic alternatives.

Vyvanse As Alternative Prescription Amid Shortages

The decision was made just in time for the back-to-school season and nearly a year after the nation began experiencing ADHD medication shortages.

In October of last year, a nationwide shortage of Adderall was caused by record-high demand and manufacturing difficulties.

The number of stimulant prescriptions (including Adderall and Vyvanse) increased by more than 45 percent between 2012 and 2021, a trend that accelerated during the epidemic.

Based on the CDC, ADHD diagnoses skyrocketed in 2020 and 2021, with prescriptions for stimulants increasing by more than 10 percent across all age groups.

As a result of the shortages, physicians began prescribing Vyvanse to their parents more frequently. From May 2022 and May 2023, approximately 30% more Vyvanse prescriptions were written. 

Unexpectedly, Vyvanse also became more difficult to obtain. Takeda disclosed supply shortages for its 40mg, 60mg, and 70mg Vyvanse capsules beforehand this summer, citing “manufacturing delay compounded by increased demand,”.

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Restriction of Production and Quotas

FDA-Grants-Approval-For-Generic-Vyvanse-To-Address-Shortfalls-Of-ADHD-Medication
Monday, the Food and Drug Administration announced that it authorized generic brands of Vyvanse, a substitute to Adderall that is becoming increasingly popular.

The way in which the pharmaceuticals are regulated may explain why the ADHD medication shortage has persisted for so long.

Adderall and Vyvanse are both Schedule II controlled substances, along with oxycodone and fentanyl, because they are deemed to have “a high potential for abuse which may lead to severe psychological or physical dependence.”

Consequently, manufacturers must adhere to production restrictions and quotas. Despite the FDA declaring an Adderall shortage in December, the DEA refused to increase production quotas.

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