Migraine Meds Epidrin, Midrin Update 1/28/11

Teri Robert @trobert Health Guide
  • As promised, I'm still following the situation with the Migraine abortive medications Midrin and Epidrin and other isometheptene mucate / dichloralphenazone / acetaminophen abortive medications. If you haven't been following this situation, or if you want to review the story so far, see Migraine and Midrin-Like Medications Update, 1/15/11.


    The basics of the situation: Midrin and almost all of the other isometheptene mucate / dichloralphenazone / acetaminophen compounds have been discontinued because they were first introduced to the market before the current FDA approval process, and the grace period for getting approval has come to an end.

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    I have contacted as many manuracturers of these medications as I could locate. Of all of them, the only one that may be continued is Epidrin, manufactured by Excellium Pharmaceuticals. At this time, they are attempting to reach an agreement with the FDA under which they could resume manufacturing and shipping Epidrin based on the research at hand and the track record for safety established since these medications first came into use. If the FDA will not agree, Excellium would need to invest millions of dollars in clinical trials, starting at the beginning and filing a new drug application with the FDA. This process would take at least two years.


    Earlier reports that we might see Epidrin back in pharmacies by early spring were based upon the hope that the FDA would accept Excellium's request for the agreement mentioned above. Hopefully, we'll know whether the FDA will accept Excellium's request for this agreement the end of next week. I'll post an update as soon as I have the information.

     

    If you need information about other Migraine abortive medications, please see Since Midrin and the generid form of Midrin have been discontinued, what drug can be used as a replacement?


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    Page copy protected against web site content infringement by Copyscape© Teri Robert, 2011
    Last updated January 28, 2011.

Published On: January 28, 2011