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Re: acgood post# 86160

Wednesday, 11/11/2009 4:11:39 PM

Wednesday, November 11, 2009 4:11:39 PM

Post# of 257662
TEVA:

so this new [Copaxone] formulation would be the basis of an ANDA because of the differences between it and the original copaxone?

No, Teva will submit “low volume” Copaxone as a supplemental NDA. (As the owner of Copaxone, Teva would not ever be the applicant for a Copaxone ANDA.)


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