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Re: jbog post# 114009

Thursday, 02/03/2011 6:32:52 PM

Thursday, February 03, 2011 6:32:52 PM

Post# of 257259
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.

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