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Adzenys XR-ODT Approval History

FDA Approved: Yes (First approved January 27, 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

Further information

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