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FDA Calendar
Event DateSymbolDrug NameEvent Name
06/20/17NEOSCotempla XR-ODT (NDA resubmission)FDA decision on Cotempla XR-ODT for the treatment of ADHD
06/20/17SHPG, SHP.LSHP465 (NDA resubmission)FDA decision on SHP465 for treatment of ADHD
06/20/17SUPNSHP465 (NDA resubmission)FDA decision on SHP465 for treatment of ADHD
06/17/17GMXAY.PK, GNMSF.OBDARZALEX in combination with pomalidomide and dexamethasone (sBLA)FDA decision on DARZALEX combination for relapsed or refractory multiple myeloma
06/14/17MRKKEYTRUDA (sBLA)FDA decision on KEYTRUDA for patients with bladder cancer, ineligible for cisplatin-containing therapy
06/14/17MRKKEYTRUDA (sBLA)FDA decision on Keytruda for second-line use in patients with bladder cancer
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FDA Device Approval
No Records Found
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