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DewDiligence

09/19/11 12:38 PM

#126760 RE: pcrutch #126758

If it was fully substitutable, then no need for labeling discussions, right?

If the product were substitutable, there would be no need for labeling discussions of any consequence. Note that branded Lovenox no longer has a Hatch-Waxman “carve-out” for the STEMI indication, as it once did (#msg-43243987).