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Mixed Amphetamine Salts & Switching Patterns

    Basic Details
    Last Updated
    Friday, March 1, 2024
    Original Posting Date
    Health Outcome(s)
    switching patterns
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    Generic mixed amphetamine salt (MAS) products, particularly the immediate-release tablet products of specific generic MAS products, have been the subject of spontaneous reports to the Drug Quality Report System, a subset of the Food and Drug Administration's (FDA) MedWatch. Most complaints described lack of effectiveness and a need for a dose increase after switching to specific generic MAS products from other MAS products. The objective of these Sentinel analyses was to examine utilization and switching patterns among adults with a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and/or narcolepsy, treated with immediate release MAS formulations in postmarketing real world settings. Results from this descriptive analysis suggest that switching appeared to correlate with the number of dispensings and the patterns of switching did not suggest increased switching away or switching back after use of the generics of interest. Based on these data, FDA determined that no regulatory action is needed at this time.