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).