NVS/Sandoz has a pending FDA 351(k) review for its Neupogen FoB called Zarzio that has already passed muster with ODAC (#msg-109613911). Teva has since 2012 sold a Neupogen FoB in the US, called Granix, that the FDA approved under the conventional BLA pathway.
Apotex also has a pending 351(k) submission for a Neulasta FoB, which was accepted by the FDA for review in Dec 2014 (#msg-109147334).
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