Tris Pharma announced that the Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for Dyanavel XR (amphetamine) Extended-Release Oral Suspension, a CII controlled substance.

The NDA submission for Dyanavel XR was based on a Phase 3 multicenter, efficacy study conducted in over 100 patients. Results from the trial demonstrated a positive outcome by meeting all the primary endpoints.

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Dyanavel XR is being developed using Tris’ innovative technology, LiquiXR, which has already been used to create other products. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for mid-October 2015.

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