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SPPI - Spectrum announces resubmitted Eflapegrastim BLA accepted for filing
Spectrum Pharmaceuticals Inc.
Spectrum Pharmaceuticals (NASDAQ:SPPI) has announced that the resubmitted Biologics License Application for Eflapegrastim has been accepted for filing. The U.S. FDA has set a Prescription Drug User Fee Act goal date of Sept. 9, 2022. “The acceptance of the BLA resubmission is an important incremental step forward in the regulatory review process,” said Tom Riga, President and CEO of Spectrum Pharmaceuticals. SPPI +7.02% premarket to $1.22.