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Domperidone as an orphan drug: initial approval and any update ?

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  • Domperidone as an orphan drug: initial approval and any update ?

    Would it be possible to get a copy of the initial FDA approval of the file 'orphan drug status', and to get an idea of how long the process might still take? Here in the UAE, we'd like to speak with the MOH pharmacology committee, to explain the case for domperidone use as a galactogogue, and it would help us to show some documentation about your initiative. Thanks

  • #2
    enruf:

    I'm about to submit another IND proposal to the FDA with a new study design. Hopefully, they will let me do the study. I'll email you directly to respond further.

    Tom Hale Ph.D.

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    • #3
      Thanks so much. It would be great to receive it before the end of October (I have been asked to speak about domperidone at a conference here).

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