Spectrum Pharmaceuticals today announced receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for Rolontis® (eflapegrastim).
Spectrum Pharmaceuticals announced the company submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for ROLONTIS (eflapegrastim).