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DewDiligence

01/25/11 12:03 PM

#113154 RE: joethdo #113151

I seem to recall posts about TEVA having "labeling discussions" with the FDA which implied potential approval of a non-substitutable generic.

See the thread from Nov 2009 starting at #msg-43206942.

Is that still in play here? Is that a way for the FDA to split the difference in this situation?

That’s still a possible outcome, I suppose, but I do not see a new signal that a non-substitutable product is what the FDA has in mind.