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HDGabor

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HDGabor

Re: circuitcity post# 277065

Saturday, 05/30/2020 11:51:14 AM

Saturday, May 30, 2020 11:51:14 AM

Post# of 426571
c-

Fda need 6 mos to review a stupid dtc ad from amrn but finished review H ANDA package in 1 mo!

Let's see it from other approach …

More likely the FDA finished review H ANDA package long time ago (ANDA was submitted on September 21, 2016) but they need 1 mo to issue an official approval meanwhile every barrier (the last one was the patent) was removed.

(Plus: they did not issued a tentative approval after Jan 27, 2020).

So, no … FDA was not fast regarding Hikma's ANDA.

Best,
G

Disclosure: I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.

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