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Re: SM2004 post# 4148

Tuesday, 02/28/2017 2:45:30 PM

Tuesday, February 28, 2017 2:45:30 PM

Post# of 4817
His response is below. I asked for the date that they responded officially but he left that out. I just sent a follow up so we'll see what they say.

Feb 27 (1 day ago)

to Edward, Ran, Marianne
Good afternoon Edward,

I am following up on whether the FDA's CRL has been answered in regards to the generic epipen application. If so, please let me know when the CRL was answered in full.

Thanks,

Zach

Edward Barger <Edward.Barger@tevapharm.com>
Feb 27 (1 day ago)

to me, Ran, Marianne
Hi,
We have responded to the FDA and continue to work with the agency towards an approved AB rate generic Epi-Pen
We expect to be in a position to launch in early 2018
Thanks