Skip to Content

Adzenys XR-ODT Approval History

  • FDA approved: Yes (First approved January 27th, 2016)
  • Brand name: Adzenys XR-ODT
  • Generic name: amphetamine
  • Dosage form: Extended-Release Orally Disintegrating Tablets
  • Company: Neos Therapeutics, Inc.
  • Treatment for: ADHD

Adzenys XR-ODT (amphetamine) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

Adzenys XR-ODT is the first extended-release orally disintegrating amphetamine tablet approved by the FDA after the clinical program established that it is bioequivalent to a previously approved mixed amphetamine salts extended-release capsule (Adderall XR®).

Adzenys XR-ODT is designed to disintegrate in the mouth instead being swallowed whole. This extended release oral dispersible amphetamine tablet is a mixture of immediate release and polymer-coated, delayed-release resin particles which is a patent-protected formulation and not a generic of other extended release amphetamine capsules. The once a day dosage is available in six different strengths to enable the healthcare provider to individualize a specific dose for each patient.

The most common side effects reported are dry mouth, loss of appetite, insomnia, headache, weight loss and nausea.

Development History and FDA Approval Process for Adzenys XR-ODT

Jan 27, 2016Approval Neos Therapeutics Announces FDA Approval of Adzenys XR-ODT (Amphetamine Extended-Release Orally Disintegrating Tablet) for ADHD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.