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Tuesday, July 07, 2020 1:53:10 PM
WRONG! "Not FDA Approved for Orphan Indication" That doesn't indicated The FDA shot down Bucillamine.
Orphan Drug Status Orphan status does not mean that FDA has approved the drug. Orphan status and FDA approval are not the same. The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/listResult.cfm
Orphan Drug Status Orphan status does not mean that FDA has approved the drug. Orphan status and FDA approval are not the same. The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/listResult.cfm
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