FDA has approved Adzenys ER, an extended release oral suspension (amphetamine) for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients age 6 or older. Neos Therapeutics of Dallas and Fort Worth, Texas, announced in a statement
that the company plans to launch Adzenys ER in January 2018.
According to the statement, Neos Therapeutics is the only company than can offer both branded amphetamine and methylphenidate therapies in extended release dosage forms. When it is available in 2018, Adenzys ER oral suspension will be the third Neos extended release product for ADHD from the company. It needs no refrigeration or reconstitution at the pharmacy. Another form of the product, Adzenys XR-ODT, is a disintegrating tablet.
“This FDA approval unlocks yet another treatment option for ADHD patients and their caregivers who are seeking a liquid extended-release amphetamine product and provides a different dosage form of our already-approved Adzenys XR-ODT,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics.