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Re: rwdm post# 164925

Saturday, 08/03/2013 4:09:06 PM

Saturday, August 03, 2013 4:09:06 PM

Post# of 257262
{{The numbers are quite different, especially in the case of Tyrosine (8.3% vs. 9.2% respectively which is a ~10% deviation). Does this mean that the similarity required by the FDA has some flexibilities?}}

We would need to know what the batch to batch variation Teva had when they received FDA approval for Copaxone.

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