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The study began with an open-label dose optimization period (4 to 6 weeks) with an initial QUILLIVANT XR dose of 20 mg once daily in the morning. The dose could be titrated weekly in increments of 10 or 20 mg until a therapeutic dose or the maximum dose of 60 mg/day was reached.
The currently recommended maximum dose is eight pills a day (4,000 mg). Today's action comes after years of consideration and actions on the federal level. Two years ago, an FDA advisory panel recommended dropping the maximum daily dose below 4,000 mg. The panel asked for a single adult dose of 675 mg. The FDA did not follow the recommendation.