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DewDiligence

02/03/11 6:32 PM

#114013 RE: jbog #114009

I presume you’re referring to the 2009 thread about “labeling discussions” starting with #msg-43193638. There’s never been another generic drug like Lovenox, so it’s hard to generalize about the FDA review procedure; it would seem to make sense for discussions about substitutability to come near the end of the review process, but they could conceivably come at any time.