SPPI - FDA delays action on Spectrum's Relontis application pending on-site inspection

Spectrum Pharmaceuticals ([[SPPI]] +2.2%) reports that the FDA will delay its decision on its marketing application for Rolontis (eflapegrastim) for the potential treatment of neutropenia in chemo patients until it conducts an on-site inspection of the Hanmi Bioplant in South Korea. The agency has been unable to complete the inspection due to COVID-19 disruptions.CEO Joe Turgeon says, “We are actively working with the FDA to find a way to expedite the plant inspection. The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible.”The company submitted the application in December 2018.

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FDA delays action on Spectrum's Relontis application pending on-site inspection