Adhansia XR FDA Approval History
Reviewed by J.Stewart BPharm. Last updated on March 20, 2019.
FDA Approved: Yes (First approved February 27, 2019)
Brand name: Adhansia XR
Generic name: methylphenidate hydrochloride
Dosage form: Extended-Release Capsules
Company: Adlon Therapeutics L.P.
Treatment for: Attention-Deficit / Hyperactivity Disorder
Adhansia XR (methylphenidate hydrochloride) is an extended-release capsule formulation of the approved central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older.
- Adhansia XR is taken orally once daily in the morning, with or without food. Capsules may be swallowed whole, or opened and the entire contents sprinkled onto a tablespoon of applesauce or yogurt. If sprinkled, the contents should be swallowed without crushing or chewing.
- CNS stimulants, including Adhansia XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Patients should be assessed for their risk of abuse prior to prescribing, and monitored for signs of abuse and dependence during treatment.
- The most common (≥5% and twice the rate of placebo) adverse reactions occurring with Adhansia XR in adults are insomnia, dry mouth, and decreased appetite. The most common (≥5% and twice the rate of placebo) adverse reactions occurring with Adhansia XR in pediatric patients are decreased appetite, insomnia, and decreased weight.
Development Timeline for Adhansia XR
|Mar 1, 2019||ApprovalFDA Approves Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules for the Treatment of ADHD|
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