This is how these drugs go through the FDA process. 'Designated' is one step-- where as being approved for orphan status is further down the line.
https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products#:~:text=Orphan%20drug%20designation%20is%20a,drug%20for%20approval%20or%20licensing.
This is how these drugs go through the FDA process. 'Designated'...
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