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home / news releases / SPPI - Spectrum Pharma announces rescheduled pre-approval inspection by the FDA

SPPI - Spectrum Pharma announces rescheduled pre-approval inspection by the FDA

Spectrum Pharmaceuticals Inc.
Spectrum Pharmaceuticals ([[SPPI]] -3.0%) has announced that the FDA has scheduled the pre-approval inspection at the ROLONTIS (eflapegrastim) manufacturing site for May 2021.“We believe the pre-approval inspection marks the final step in the ROLONTIS review process,” noted Spectrum Pharma CEO, Joe Turgeon.ROLONTIS is a long-acting granulocyte colony-stimulating factor (G-CSF) seeking to treat neutropenia in patients receiving myelosuppressive anti-cancer drugs.The company reported in October that the FDA had delayed the review of its marketing application until the completion of on-site inspection of the Hanmi Bioplant in South Korea which had been delayed due to COVID-19 related disruptions.

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Spectrum Pharma announces rescheduled pre-approval inspection by the FDA
Stock Information
Company Name: Spectrum Pharmaceuticals Inc.
Stock Symbol: SPPI
Market: NASDAQ
Website: sppirx.com
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