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ThomasS

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ThomasS

Re: zipjet post# 56310

Tuesday, 12/18/2007 8:16:32 AM

Tuesday, December 18, 2007 8:16:32 AM

Post# of 257257
MNTA: Perhaps the FDA has not completed their review of each respective application for Teva/Amphastar. Regardless, immunogenicity will be a concern for both of those companies.
MNTA received a "not approvable" letter because the FDA didn't want (apparently) to reject the app outright; additionally, an "approvable letter" mechanism isn't in place for ANDA's.

"Illegitimacy is something we should talk about in terms of not having it."

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