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news.Neos Therapeutics announced that Adzenys XR-ODT is in distribution channels and is now available to prescribe to patients with ADHD in the US.
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Adzenys XR-ODT was approved by the U.S. Food and Drug Administration (FDA) in January for the treatment of ADHD in patients six years and older and is the first and only extended-release orally disintegrating tablet (XR-ODT) for the treatment of ADHD.
Adzenys XR-ODT is bioequivalent to Adderall XR, one of the most commonly prescribed medications for the treatment of ADHD.
"The availability of the first and only extended-release orally disintegrating tablet for the treatment of ADHD represents a significant milestone for patients and families that struggle with ADHD," said Thomas McDonnell, Chief Commercial Officer of Neos.
"Adzenys XR-ODT offers patients, caregivers and health care providers an important new option for the treatment of ADHD that was designed with patients in mind."
Adzenys XR-ODT is an orange-flavored tablet that disintegrates in the mouth without water. The medication is available in six dosage strengths and has the convenience of once-daily dosing.
"The availability of Adzenys XR-ODT marks the first branded product launch for Neos using our proprietary extended-release, orally disintegrating tablet technology," said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics.
"Neos is committed to addressing individual patient needs by delivering new treatment options for those with chronic disorders like ADHD. In addition to Adzenys XR-ODT, we look forward to pursuing FDA approval of our two additional late-stage product candidates for ADHD, and utilizing our technology platform in other therapeutic areas."