Related by context. Frequent words. (Click for all words.) 56 Mutual Recognition Procedure 56 Marketing Authorization Application MAA 56 Marketing Authorization Application 55 Paragraph IV 55 Marketing Authorization 55 Complete Response 54 Biologics License Application BLA 54 Pivotal Phase III 54 supplemental Biologics License Application 53 orphan designation 53 Complete Response letter 53 USFDA approval 53 INDs 52 Biologics License Application 52 Phase III Clinical Trial 52 Rhucin ® 52 Drug Application 52 Drug Candidate 51 Clevudine 51 Orphan Drug Status 51 sBLA 51 Citizen Petition 50 Rhucin 50 USFDA 50 BLA submission 50 biogeneric 49 Paragraph IV certification 49 SFDA approval 49 Orphan Drug status 49 ANDAs 49 Synthon 48 Orphan Drug designation 48 ponatinib 48 Nexavar ® 48 Avastin bevacizumab 47 DCGI 47 voclosporin 47 Telavancin 47 SPD# 47 QRxPharma 47 Pharmexa 47 Vitaros 47 Paladin Labs 47 alogliptin 47 Ondansetron 47 Investigational 47 metastatic hormone refractory 47 silodosin 47 Loramyc ® 47 pediatric exclusivity 46 CHMP opinion 46 rhC1INH 46 Zactima 46 GEM #S 46 Notified Body 46 Drug Administration USFDA 46 HCV protease inhibitor 46 ALN TTR# 46 BioDelivery Sciences 46 Pivotal Phase 45 BEMA Fentanyl 45 Swissmedic 45 Orphan Drug Designation 45 Amrubicin 45 ATryn ® 45 Oxandrin 45 Sensipar 45 Approvable Letter 45 TREANDA 45 OTCQX RHHBY 45 Nimotuzumab 45 methylnaltrexone 45 SFDA 45 Cimzia ® 45 Barr Laboratories Inc. 45 NOXXON 45 Photocure 45 prGCD 45 mTOR inhibitor 45 liprotamase 45 Medi Span 45 orphan medicinal product 45 fusion inhibitor 45 registrational 44 DAVANAT R 44 Icatibant 44 European Medicines Evaluation 44 registrational trial 44 apaziquone 44 Vilazodone 44 Orphan Medicinal Product 44 diabetic neuropathic pain 44 Onsolis 44 IND submission 44 ScinoPharm 44 ATryn R 44 Jerini 44 PREOS 44 Priority Review 44 anticancer compound 44 '# '#