Skip to main content

Focalin XR FDA Approval History

FDA Approved: Yes (First approved May 26, 2005)
Brand name: Focalin XR
Generic name: dexmethylphenidate
Dosage form: Extended-Release Capsules
Company: Novartis Pharmaceuticals Corporation
Treatment for: ADHD

Focalin XR (dexmethylphenidate) is a once-daily extended-release form of Focalin indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children.

Development timeline for Focalin XR

Nov 12, 2008Approval FDA Approves 30-Minute Onset of Action for Focalin XR
May 26, 2005Approval Focalin XR Novartis Pharmaceuticals Corporation - Treatment for Attention-Deficit/Hyperactivity Disorder (ADHD)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.