Related by context. Frequent words. (Click for all words.) 67 approvable letter 66 Complete Response letter 64 Approvable Letter 61 Complete Response Letter 61 FDA 60 CHMP 60 Marketing Authorization Application 59 pediatric exclusivity 59 European Medicines Evaluation 59 Marketing Authorization 58 DCGI 58 cladribine 58 Torisel 58 Priority Review 58 PDUFA date 57 Horizant 57 Arzerra 57 Afrezza 57 European Medicines Agency 57 Bydureon 57 Biologics License Application 57 alogliptin 57 iloperidone 57 sNDA 57 Drug Administration USFDA 56 asenapine 56 biogeneric 56 FDA reviewers 56 USFDA 56 eltrombopag 56 Trexima 56 ANDAs 56 abatacept 56 Treximet 56 ustekinumab 56 motavizumab 56 Replagal 56 Treanda 56 sBLA 55 BYDUREON 55 Orphan Drug designation 55 Encysive 55 Biologics License Application BLA 55 Gilenia 55 Galvus 55 Cladribine Tablets 55 Lumizyme 55 SEROQUEL XR 55 Seroquel XR 55 Swissmedic 55 Marketing Authorization Application MAA 55 NDAs 54 Cimzia ® 54 Ampligen 54 Medicinal Products 54 NUVIGIL 54 Clolar 54 Apricus Bio 54 Thyrogen 54 Esbriet 54 methylnaltrexone 54 Exalgo 54 BENLYSTA 54 Orphan Drug Designation 53 Drug Application 53 Exanta 53 Prexige 53 Rhucin 53 ONSOLIS 53 Entereg 53 Mylotarg 53 Frova 53 fingolimod 53 biosimilar 53 PDUFA 53 Fast Track designation 53 TORISEL 53 Antegren 53 Vasovist 53 INDs 53 Drug Administration FDA 53 Cubicin 53 Synvisc One 53 Drug Administration 52 belatacept 52 Aclasta 52 Actemra 52 PROMACTA 52 maraviroc 52 Warning Letter 52 VPRIV 52 bifeprunox 52 Prezista 52 Drugs Advisory 52 vandetanib 52 ecallantide 52 velaglucerase alfa 52 Fanapt 52 Cimzia 51 Opana ER 51 Sprycel