- In a regulatory filing, Spectrum Pharmaceuticals (NASDAQ:SPPI) discloses that it has resubmitted its New Drug Application (NDA) to the FDA for Orphan Drug-tagged EVOMELA (melphalan) for the conditioning treatment prior to hematopoietic stem cell transplant in multiple myeloma patients or palliative treatment of multiple myeloma. The FDA's decision date (PDUFA) is May 9, 2016.
- The company received a Complete Response Letter (CRL) in October in response to its initial submission.
- Previously: No FDA approval for Spectrum Pharma's CE-Melphalan NDA, CRL received; shares down 21% premarket (Oct. 23)