US Allows ADHD Drugmaker To Increase Production Limit To Ease Ongoing Shortage

Sep 06, 2024
News

ADHD drugs have been in short supply for years and the FDA warned of their scarcity in 2022 (Pic: Getty Images)

The United States Drug Enforcement Administration has increased the production limit for Takeda Pharmaceutical’s ADHD drug Vyvanse and its generic versions by about 24 per cent to address the ongoing shortage in the country.
The move follows the FDA's request in July, according to the DEA.
While ADHD drugs have been in short supply for years, the FDA warned of a scarcity of Israel-based drugmaker Teva Pharmaceutical Industries’ Adderall in October 2022, troubled by manufacturing delays, which led to a spike in demand and subsequent shortage of Takeda’s Vyvanse.
According to NBC News, the production limit for lisdexamfetamine was increased by 6,236 kilograms, which includes 1,558 kg to address increased domestic demand and 4,678 kg for increased foreign demand for finished dosage medications, the DEA informed. “These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs domestically and globally,” DEA said.
The FDA approved generic versions of Vyvanse from 11 drugmakers, including U.S.-based drugmakers Mallinckrodt and Viatris, UK-based Hikma Pharmaceuticals, and Indian drugmaker Sun Pharmaceutical Industries, last year after Takeda lost exclusivity over the drug.

What is Vyvanse?

Also known as lisdexamfetamine, Vyvanse is classified by the DEA as a schedule-II controlled substance, which is applied to drugs considered to have a high likelihood of being abused, and additional prescribing safeguards are put in place.
It is commonly used for the treatment of ADHD - a condition that affects people’s ability to focus and self-control and Binge eating disorder - a condition where people cannot stop eating, even when they feel very full. Lisdexamfetamine may also be used for other conditions determined by your healthcare provider. According to the FDA, it is a part of a group of medicines known as stimulants - which help increase attention and decrease impulsiveness in those with ADHD.
According to the Centers for Disease Control and Prevention, an estimated 7 million or 11.4 per cent of US children aged 3–17 years have ever been diagnosed with ADHD with national survey of parents.

What is the dosage?

Lisdexamfetamine is available as Vyvanse and generic lisdexamfetamine in the following dosage forms that are taken by mouth.
  • 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg chewable tablets
  • 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg oral capsules

What is ADHD?

Attention-deficit/hyperactivity disorder is a developmental disorder that affects a person's ability to focus, be still, and control their impulses. It is among the most common mental disorders in children, with symptoms like:

Inattention

Not being able to focus

Hyperactivity

Excess movement that's not appropriate for the setting

Impulsivity

Acting without thinking

Restlessness

Feeling edgy all the time

Speaking out of turn

Blurting out responses and interrupting others

Mood swings

Irritability and a quick temper
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