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Adzenys XR-ODT FDA 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 Timeline for Adzenys XR-ODT

DateArticle
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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