Fol­low­ing CRL, Re­vance says it's clear on in­struc­tions for re­sub­mit­ting BLA

In Oc­to­ber, the FDA hand­ed Re­vance Ther­a­peu­tics a CRL for its botox-based frown line ther­a­py, and the com­pa­ny said that the de­fi­cien­cies stemmed from a man­u­fac­tur­ing site. Now, the com­pa­ny says it has re­ceived the Type A meet­ing min­utes, and clear in­struc­tions for ad­dress­ing the short­com­ings.

Re­vance must pro­duce three con­sec­u­tive drug sub­stance lots and one drug prod­uct lot for Dax­i­bot­u­linum­tox­i­nA for In­jec­tion for glabel­lar lines, in or­der to re­sub­mit its BLA, the com­pa­ny said. This was de­ter­mined in a Dec 15 meet­ing. An­oth­er in­spec­tion of the man­u­fac­tur­ing site in north­ern Cal­i­for­nia will be re­quired af­ter the re­sub­mis­sion. The FDA has up to six months to com­plete the in­spec­tion and re­view.

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