The FDA has assigned a six-month review period for the resubmitted application and provided November 13, 2021 as the target Prescription Drug User Fee Act (PDUFA) action date.
U.S. FDA Accepts PharmaEssentia’s BLA Resubmissi... - MPN Voice
U.S. FDA Accepts PharmaEssentia’s BLA Resubmission for Besremi
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Manouche
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2 Replies
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That's good news. Perhaps we will then have it available in the Uk. Thanks for posting information.
Thanks for the update Manouche.
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