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Replies to #86160 on Biotech Values
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DewDiligence

11/11/09 4:11 PM

#86162 RE: acgood #86160

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.)