Related by context. Frequent words. (Click for all words.) 71 Approvable Letter 70 Complete Response letter 70 Marketing Authorization Application 68 Complete Response Letter 68 Biologics License Application BLA 68 Biologics License Application 66 alvimopan 66 sBLA 65 PROMACTA 65 sNDA 64 Marketing Authorization Application MAA 64 Act PDUFA date 64 New Drug Application 64 Priority Review 63 L MTP PE 62 ADVEXIN 62 PREOS 61 eltrombopag 61 Phenoptin 61 methylnaltrexone 61 teduglutide 61 TORISEL 61 NDA submission 61 Fast Track Designation 60 Marketing Authorization 60 Phase III Trial 60 BYDUREON 60 Zenvia 60 Warning Letter 59 LymphoStat B 59 CoFactor 59 Drug Candidate 59 Welchol 59 REVLIMID R 59 MOZOBIL 59 Ampligen R 59 Jevtana 59 vilazodone 59 BENLYSTA 59 ZYBRESTAT 59 Torisel 59 orphan designation 59 febuxostat 59 approvable letter 59 TREANDA 59 Genasense 59 muraglitazar 59 Marqibo 59 PhosLo 59 Vilazodone 59 European Medicines Evaluation 59 Orphan Drug status 58 pralatrexate 58 PXD# 58 maribavir 58 PDUFA date 58 ridaforolimus 58 Drug Application 58 Clolar 58 APF# 58 alogliptin 58 pegloticase 58 talactoferrin 58 Staff Determination Letter 58 FDA Approval 58 Oral Suspension 58 PS# [001] 58 SEROQUEL XR 58 axitinib 58 fidaxomicin 58 Pixantrone 58 orBec R 58 Horizant 58 Fast Track designation 58 Ceplene 58 NUVIGIL 58 SILENOR TM 57 TELCYTA 57 Acetavance 57 bazedoxifene 57 Xcytrin 57 Taxotere ® 57 Rhucin ® 57 Paragraph IV certification 57 bifeprunox 57 Bronchitol 57 Exalgo 57 Oracea 57 iloperidone 57 Bevacizumab 57 resubmission 57 ONGLYZA 57 ecallantide 57 INCB# [002] 57 orphan medicinal product 57 Mylotarg 57 Naglazyme 57 Orphan Drug Designation 57 Promacta 57 FENTORA 57 Restanza