Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pan­dem­ic re­spon­si­bil­i­ties, the agency is be­gin­ning to miss PDU­FA dates with more fre­quen­cy too. Two dif­fer­ent com­pa­nies on Mon­day said they re­ceived no­tices that the FDA has not com­plet­ed their drug re­views on time.

The re­view of an NDA for Avadel Phar­ma­ceu­ti­cals’ can­di­date treat­ment for nar­colep­sy is not com­ing this month, the com­pa­ny said, and the re­view of UCB’s BLA for bimek­izum­ab, used to treat mod­er­ate to se­vere plaque pso­ri­a­sis, will miss its tar­get date as well.

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