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Tekterra

09/28/16 4:30 PM

#18466 RE: WeeZuhl #18453

Weez, no one claimed it was crush proof. It deter, not prevent. The FDA is well aware and reasonable that nothing will PREVENT abuse, but they want products that turns people away from abusing it.

IPCI never claimed Rexista was "Crush proof." They don't need to proven that at all for the NDA submission.

Blue dye deters abuse it becomes valid ingredient that serves a purpose. Even if the abuser spent 15 minutes scrubbing it off, it makes it that much more troublesome to the abuser. And, that's exactly what the FDA wants in a product.