NEW DRUG APPROVALS Adzenys XR-ODT for ADHD
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چکیده
NEW DRUG APPROVALS Adzenys XR-ODT for ADHD The FDA has given the green light to Adzenys XR-ODT (Neos Therapeutics) for the treatment of attention -deficit/ hyperactivity disorder (ADHD) in patients 6 years of age and older. With this approval, the product is the first extended-release orally disintegrating tablet (ODT) for this indication. Adzenys XR-ODT contains amphetamine loaded onto a mixture of immediate-release and polymer-coated, delayedrelease resin particles. The treatment is patent-protected and is not a generic version of mixed amphetamine salts extended-release (MAS-XR) capsules. The clinical program demonstrated that Adzenys XR-ODT is bioequivalent to a previously approved MAS-XR capsule (Adderall XR, Shire), one of the most commonly prescribed medications for the treatment of patients with ADHD. Adzenys XR-ODT will be available in six dosage strengths equivalent to the Adderall XR dosage strengths. Source: Neos Therapeutics, January 27, 2016
منابع مشابه
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