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MTB

Re: pollyvonwog post# 13343

Thursday, 04/16/2015 5:35:09 PM

Thursday, April 16, 2015 5:35:09 PM

Post# of 20689
Why in the world would they do that? Look at the original press releases. They make it clear that Mylan will be representing Natco in the U.S. (post # 63353) -- not making a new product.

The continuation of the FDA's thought from this morning might be interesting to some.

In other words, the quantitative characterization of the proposed generic samples is consistent with the same characterization of Copaxone, taking into account its batch-to-batch variability. Because these tests clearly distinguish products that meet active ingredient sameness
criteria described above from those that would not meet these sameness criteria, these tests, while not currently considered by FDA to be necessary to establish active ingredient sameness, confirm and validate the robustness of criteria described above to assess the sameness of glatiramer acetate.