Spectrum Pharmaceuticals Provides BLA Filing Update for ROLONTIS® (eflapegrastim)
Spectrum Pharmaceuticals, Inc. (SPPI)
Last spectrum pharmaceuticals, inc. earnings: 2/27 04:00 pm
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US:NASDAQ Investor Relations:
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Source: Business Wire
HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI) announced today that due to the U.S. Food and Drug Administration’s (FDA) request for additional manufacturing-related information for ROLONTIS, the company has voluntarily withdrawn its Biologics License Application (BLA). Spectrum plans to resubmit a revised BLA as soon as possible. The FDA did not cite concerns related to the pre-clinical and clinical modules of the BLA or the need for additional clinical studies. Spectrum’s decision to withdraw the BLA was the result of the company needing more time to provide certain additional manufacturing-related information, which was required before March 29, 2019, the day that the FDA’s initial 60-day review period ends. “We are continuing to have productive discussions with the FDA and will deliver the additional information needed to support the application,” said Joe
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