Elite Pharmaceuticals Inc (ELTP): unsafe Tmax delay Who determined thi...

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Elite Pharmaceuticals Inc (ELTP)

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Re: namtae post# 237101

Monday, 12/26/2016 4:52:06 PM

Monday, December 26, 2016 4:52:06 PM

unsafe Tmax delay

Who determined this to be unsafe?

There are many IR opioids that have a time to maximum concentration issue.......

This was supposed to be a labeling issue and then the
FDA did a 180 on Elite after the BE trials were completed.

So now this is an "unsafe Tmax delay"? The FDA did not say that. So who did?
If this was an "unsafe Tmax delay" there would be no way to get approval for this formulation. Since there is a way to get approval for this formulation this must be a safe formulation per the FDA.

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