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