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Liquid Adzenys ER Approved by FDA

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Liquid Adzenys ER Approved by FDA

  • Julie Warshaw
  • September 28, 2017


September 28, 2017

The FDA has approved Adzenys ER, an extended-release liquid amphetamine medication, for the treatment of ADHD in patients 6 years and older. The once-daily formulation is expected to be on the market in early 2018.

The news was announced in a press release by Adzenys ER’s manufacturer, Neos Therapeutics, which also produces Adzenys XR-ODT, an orally disintegrating amphetamine tablet. Adzenys — in both tablet and liquid form — is considered to be the bioequivalent to Adderall. Neos also makes Cotempla XR-ODT, an orally disintegrating methylphenidate; both Cotempla and Adzenys XR were approved by the FDA in the last two years.

Adzenys ER is an orange-flavored liquid with a strength of 1.25 mg/ml. It will be sold in 450 ml bottles, and does not need to be refrigerated. Side effects for Adzenys ER are reported to be similar to those of other amphetamine products, and include dry mouth, decreased appetite, sleep disturbances, and mood changes.