Related by context. Frequent words. (Click for all words.) 56 sNDA 56 NDA submission 55 New Drug Application 55 Complete Response Letter 54 PDUFA date 54 submittal 54 approvable letter 51 approvable 50 sBLA 50 resubmit 48 APF# 48 Priority Review 48 Marketing Authorization Application MAA 48 resubmitted 47 Marketing Authorization Application 47 Marqibo 46 Act PDUFA 45 BLA 45 vilazodone 44 Environmental Impact Statement EIS 44 Fast Track designation 44 resubmitting 44 IND enabling 42 Surfaxin 42 BYDUREON 42 pralatrexate 42 IND 41 KRYSTEXXA 41 CHMP 41 GATTEX 41 CORLUX 41 MAA 41 PRX # 41 ANDA 41 indiplon 40 Clolar 40 Iluvien 40 oritavancin 40 Dyloject 40 Investigational 40 Zerenex 40 Phase IIa trial 40 naproxcinod 40 fidaxomicin 40 initiate Phase 40 Kuvan 39 ANDAs 39 submission 39 submittals 39 confirmatory Phase 3 39 Mozobil 39 reconsideration 39 clofarabine 39 Phase 2b 39 investigational compound 39 Drug Application 39 pivotal Phase 39 redesignation 38 RFQ 38 Intermezzo R 38 Phase 1b 38 ADVEXIN 38 milnacipran 38 Entereg 38 Zenvia 38 Orphan Drug Designation 38 Phase IIb trial 38 phase IIb 38 orally administered 38 Phase II 38 Environmental Impact Statement 38 Ceplene 38 lubiprostone 38 Abbreviated New 37 Phase III trials 37 refiling 37 Pennsaid 37 schematic design 37 Phase Ib 37 satraplatin 37 Phase 2b trial 37 Bronchitol 37 IMGN# 37 NGX# 37 Qutenza 37 voreloxin 37 Topical Interferon Alpha 2b 37 regulatory approval 37 Phase III clinical trials 37 END FOOTNOTE 37 Orphan Drug 37 AP# [003] 37 Phase 2b study 36 Acurox 36 application 36 Phase III 36 Antegren 36 EIR 36 submitted 36 RDEA# 36 pivotal Phase III