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November 5, 2021 – A new dosage form of Dyanavel XR® (amphetamine) has received U.S. FDA approval to treat attention deficit hyperactivity disorder (ADHD) in patients who are at least six years old. Previously available only as an oral suspension, Dyanavel XR is now available in extended-release oral tablets.
- The new tablets are bioequivalent to the oral suspension, meaning patients can easily switch from one dosage form to another. The oral tablets can be substituted for the oral suspension (or vice versa) on a milligram per milligram basis.
- Recommended dosing is 2.5mg or 5mg once daily in the morning to start. The dosage can be increased in increments of 2.5mg to 10mg per day every four to seven days, up to a maximum daily dose of 20mg.
- Manufacturer Tris Pharma expects Dyanavel XR oral tablets to be available for dispensing in the first quarter of 2022. Pricing is not yet available.