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Re: DewDiligence post# 194780

Wednesday, 11/18/2015 10:18:19 AM

Wednesday, November 18, 2015 10:18:19 AM

Post# of 251670
FDA reviewing NVS’ 351(k) submission for Neulasta FoB:

https://www.novartis.com/news/media-releases/regulatory-submission-sandoz-proposed-biosimilar-pegfilgrastim-accepted-fda

NVS seeks FDA approval of the FoB for all of Neulasta’s approved indications (as was the case with NVS’ Zarxio FoB for Neupogen).

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