No, that's the approval letter from this year. I'm referring to the non approvable letter of 11/6/07. Is that one public? There are some holes in the immunogenicity data for bioequivalence case. Wheeler said "In a follow-up call, the FDA clarified that all applications for enoxaparin products must address the potential for immunogenicity of the drug product." Does that sound like a request for bioequivalence data? Going back over the use of the term in the CP, the FDA never really uses the term immunogenicity in relation to bioequivalence, either. It seems more concerned with immune response.
Going to be an interesting hearing in August. It's just strange that SNY would use this argument. Take away the immunogenictiy data, the FDA could approve it anyway, based on the sameness of the active ingredient.
Regards, RockRat
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