Adhansia XR Approval History
Reviewed by J.Stewart BPharm Last updated on Mar 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 History and FDA Approval Process for Adhansia XR
|Mar 1, 2019||FDA Approves Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules for the Treatment of ADHD|
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