The US FDA has had to delay the possible marketing approval of Hanmi Pharmaceutical Co., Ltd. and Spectrum Pharmaceuticals Inc.’s novel long-acting neutropenia drug Rolontis (eflapegrastim) because of the impact of the COVID-19 pandemic on its ability to conduct plant inspections.
Inspection Delay Puts Back Hanmi/Spectrum’s Rolontis
US Action Date Now Set For Feb '21
US FDA defers action on Spectrum’s approval application for neutropenia candidate Rolontis due to pandemic-related difficulties inspecting partner Hanmi’s plant. The action date has been put back although the companies stress no CRL has been issued.
