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DewDiligence

02/11/17 4:07 PM

#16625 RE: rwwine #16622

I agree. There is no legal or regulatory impetus for the FDA to hold up one ANDA in order to approve it simultaneously with other ANDA(s). To the contrary, the FDA's GDUFA regs prioritize the review of the first ANDA for drugs that have no generic competition.