SPPI - FDA initiates pre-approval inspection for Spectrum pharmaceuticals' ROLONTIS

Spectrum Pharmaceuticals (SPPI) announces that the U.S. FDA has initiated a pre-approval inspection for ROLONTIS (eflapegrastim).Shares up more than 3% premarket.ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor ((G-CSF)) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs.The company said that the health regulator is "on site" for the ROLONTIS manufacturing facility inspection.Spectrum previously received notification from the agency that it would defer its decision on the BLA for ROLONTIS because an inspection of the Hanmi Bioplant in South Korea could not be conducted due to restrictions on travel related to the COVID-19 pandemic.

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FDA initiates pre-approval inspection for Spectrum pharmaceuticals' ROLONTIS