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Tekterra

07/25/17 1:23 PM

#28483 RE: AngeloFoca #28471

If what this author saying is true, IPCI is only seeking IV abuse label at this time which is a smart move due to exclusives still in effect for nasal route. They are trying to avoid the pitfall EGLT ran into. The blue dye is obviously new and different so that's a factor for the committee to decided. No food effect, and bio equivalent there are considerable benefits that comes with Rexista. Because the goal is to evaluate the benefits should out weigh the negatives. There is probably a good chance of a favorable recommendation.

IV route is probably not an issue, the crush and snort it deterred by the dye. No alcohol dose dump, hard to extract the content is a plus.