News Focus
News Focus
icon url

DewDiligence

03/05/17 7:06 PM

#209633 RE: Double_Bagel #209630

Re: MYL’s Copaxone ANDAs

Please see #msg-112812696, #msg-112817624, #msg-112848073, and #msg-112804827 for comments on this question. Also, bear in mind that the FDA has had MYL’s 20mg-Copaxone ANDA under review for 7.5 (!) years (#msg-41441618); if MYL truly understood how to replicate Copaxone, one would think they would have approval of the 20mg ANDA by now.