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Lawyer for Alabama Pharmacy Board Hearing – Call today to discuss your case – FDA Approves First Orally Dissolvable Methylphenidate Tablets for ADHD – (866) 348-2889
Officials with the FDA have approved methylphenidate (Cotempla XR-ODT, Neos Therapeutics) extended-release orally disintegrating tablets. The tablets are indicated to treat attention-deficit/hyperactivity disorder (ADHD) in patients aged 6-17 years old.
The approval is based on data from a phase 3 clinical trial that supports the safety and efficacy of Cotempla XR-ODT. In the trial, treatment demonstrated a statistically significant improvement in ADHD symptoms compared to a placebo in children in a laboratory classroom. The drug’s effectiveness was indicated at 1 hour after the dose was received and lasted for 12 hours. No serious adverse events were reported.