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  • 1.  Rx to OTC Switch

    This message was posted by a user wishing to remain anonymous
    Posted 04-Oct-2018 10:25
    This message was posted by a user wishing to remain anonymous

    Can a company initiate a switch of an Rx product to OTC if they are not the NDA or ANDA holder?  Would this be done via 505(b)(2)?  Are there any examples of this being done?


  • 2.  RE: Rx to OTC Switch

    Posted 05-Oct-2018 08:48
    In the attached presentation from FDA, it is suggested that "other parties" can submit a Citizen Petition with a full data package to request the switch.

    https://www.fda.gov/downloads/drugs/newsevents/ucm454815.pdf

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


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