Regulatory Open Forum

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  • 1.  Proprietary Names

    Posted 12-Jun-2018 08:40
    We have a client trying to obtain a proprietary name. Lists and lists have been generated and run through POCA, but we are unable to find one that is 50 or less as stated in the guidance. We are up to four syllable names with really odd letter combinations. Any suggestions or ideas would be greatly appreciated.

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    Ruth Collins RAC
    Manager Regulatory Affairs
    Euless TX
    United States
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  • 2.  RE: Proprietary Names

    Posted 13-Jun-2018 08:42
    Hi Ruth,

    It's my understanding that names that have a POCA of above 50 can still be acceptable since the number generated by POCA doesn't take other factors into consideration, like disease state and dosage form of the products/names that the system considers a close match, and is simply analyzing the names from the (perceived) sound and spelling. 

    Best of luck!
    Courtney

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    Courtney Portik
    Atlanta, GA
    United States
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