Adderall XR Global Regulatory Status: FDA Approval, International Controls, and Label Updates

When was Adderall XR approved, and for what?

Adderall XR is Takeda's once-daily extended-release capsule of mixed amphetamine salts, approved under NDA 021303 on 11 October 2001 as a type 3 new dosage form [1]. It comes in 5, 10, 15, 20, 25 and 30 mg capsules and is prescription only [1]. The approved indication is ADHD in adults and children 6 years and older; the label says it is not recommended under age 6, who have higher plasma exposure and more adverse reactions such as weight loss, and narcolepsy is not an Adderall XR indication [1].

The immediate-release tablets are a separate application, NDA 011522, with an original approval date of 19 January 1960; their label covers ADHD and narcolepsy. Drugs@FDA lists the brand Adderall tablets as discontinued, while generic mixed amphetamine salts tablets are widely approved [3].

What does Schedule II status mean?

The Adderall XR label states the capsule contains mixed amphetamine salts, a Schedule II controlled substance, with a high potential for abuse and misuse and a risk of diversion for non-medical use [1]. The boxed warning says misuse and abuse of CNS stimulants can result in overdose and death, with higher risk at higher doses or with unapproved routes such as snorting or injection [1].

What do the sport rules say?

WADA's 2026 Prohibited List names amfetamine, including its optical isomers, in class S6.A (non-specified stimulants), prohibited in-competition, and the 2027 List, in force from 1 January 2027, still names it [2][4]. Use in WADA-governed sport requires a Therapeutic Use Exemption [2].

What does the current label warn about?

The label in force is dated 30 April 2026 [1]. Sudden death has been reported with CNS stimulants at recommended ADHD doses in patients with structural cardiac abnormalities or other serious cardiac disease. The label says to avoid these drugs in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmia, coronary artery disease or other serious cardiac disease. Stimulants raise blood pressure by about 2 to 4 mm Hg and heart rate by about 3 to 6 beats per minute on average [1]. New psychotic or manic symptoms occurred at recommended doses in about 0.1% of stimulant-treated patients versus 0% on placebo in pooled short-term trials [1]. The contraindications are hypersensitivity to amphetamine or other components, and MAOI use or use within 14 days of stopping one, including linezolid and intravenous methylene blue, because of hypertensive crisis [1].