FDA approves Adzenys ER for ADHD treatment

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Adzenys ER is a once-daily extended-release liquid that does not need to be reconstituted or refrigerated
Adzenys ER is a once-daily extended-release liquid that does not need to be reconstituted or refrigerated

Neos Therapeutics announced that the Food and Drug Administration (FDA) has approved Adzenys ER (amphetamine) extended-release oral suspension for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged ≥6 years.

Adzenys ER is a once-daily extended-release liquid that does not need to be reconstituted or refrigerated. Other ADHD extended-release medications from Neos include Adzenys XR-ODT (amphetamine) extended-release orally-disintegrating tablets and Cotempla XR-ODT (methylphenidate) extended-release orally-disintegrating tablets. 

Adzenys ER and Adzenys XR-ODT are considered bioequivalent to Adderall XR. Amphetamines are non-catecholamine sympathomimetic amines with central nervous system (CNS) stimulant activity; the exact mechanism of action is unknown. 

Adzenys ER, a CII controlled substance, will be available as a 1.25mg/mL strength orange-flavored suspension in 450mL bottles. It is expected to launch early next year.

Reference

  1. Neos Therapeutics receives U.S. FDA approval of Adzenys ER™ (amphetamine) extended-release oral suspension for the treatment of ADHD in patients 6 years and older [press release]. Neos Therapeutics. September 15, 2017

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