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Re: mouton29 post# 109461

Wednesday, 11/24/2010 12:40:31 PM

Wednesday, November 24, 2010 12:40:31 PM

Post# of 257250
Unlike Lovenox, Copaxone does not have any “junk” that needs to be characterized (#msg-56267201), which makes Copaxone an easier task for MNTA to replicate, all told, than Lovenox was.

The FDA’s published guidance for what is required for approval of generic Copaxone will probably end up being taken from MNTA’s application, as was the case with Lovenox.

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