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  • 1.  Bringing back a discontinued NDA

    Posted 17-Feb-2017 11:11
    If an NDA has been discontinued (marketing, not safety reasons) by an application holder, what would need to be done to reactivate it?  If another company wants to license and market the product from the original application holder what would need to be done?

    Thank you,

    Marcy

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    Marcy Sussman RAC
    Potomac MD
    United States
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  • 2.  RE: Bringing back a discontinued NDA

    Posted 02-May-2017 15:44
    Dear Marcy,

    Discontinued or Withdrawn?  Is it listed in the Orange Book? "a cumulative list of approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn for safety or effectiveness reasons, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing"
    Are you looking to submit a 505(b)(2) or ANDA?  Is the other company looking to purchase the discontinued product (not withdrawn and discontinued for less than 2 years) from the original NDA holder?

    Best Regards,

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    Tyng-Yi (Tina) Lee MS RAC
    Consultant
    North Brunswick NJ
    United States of America
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    Original Message


  • 3.  RE: Bringing back a discontinued NDA

    Posted 02-May-2017 19:30
    Please check the below link that may answer your question.

    Waking From a Drug Coma: How to Bring a Drug Out of Discontinued Status - It's As Easy As 1, 2, 3 . . . 4, and 5
    FDA Law Blog remove preview
    Waking From a Drug Coma: How to Bring a Drug Out of Discontinued Status - It's As Easy As 1, 2, 3 . . . 4, and 5
    By Kurt R. Karst - Finger through the "Discontinued Drug Product List" section of the Orange Book and youl'll quickly realize that there are a lot of drug products no longer marketed. The "Discontinued Drug Product List" spans 337 pages...
    View this on FDA Law Blog >


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    Gaurang Bhavsar
    Edison NJ
    United States
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    Original Message


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