Related by context. Frequent words. (Click for all words.) 71 Risk Evaluation 70 Medication Guide 64 REMS 63 Boxed Warning 59 full Prescribing Information 58 Full Prescribing Information 57 Prescribing Information 56 pseudobulbar affect PBA 56 ONSOLIS 56 Icatibant 55 alvimopan 55 PREOS 55 Onsolis 54 Act PDUFA date 54 Exalgo 54 FENTORA 54 Thyrogen 54 Telavancin 53 pharmacovigilance 53 INTELENCE 53 NUVIGIL 53 FIRAZYR 52 Horizant 52 injection USP 52 approvability 52 Neurodex 52 6R BH4 52 PhosLo 52 BLA submission 52 Cimzia R 52 NOXAFIL 52 LIALDA 52 liprotamase 52 tapentadol 52 XEOMIN 52 oral anticoagulant 52 JANUMET 51 Relistor 51 Entereg 51 proton pump inhibitors PPIs 51 Keppra R 51 European Medicines Evaluation 51 NEBIDO 51 Shire ADHD 51 diabetic peripheral neuropathic pain 51 Keppra ® 51 Tygacil 51 Vilazodone 51 regadenoson 51 NDA submission 51 Complete Response 51 Seroquel XR 50 Opana ER 50 Protopic 50 Myobloc 50 Mutual Recognition Procedure 50 pancreatic enzyme 50 FDA 50 ATryn ® 50 supplemental Biologics License Application 50 Symbyax 50 Research CDER 50 Duloxetine 50 bazedoxifene 50 CYCLOSET 50 Extavia 50 Zelrix 49 Lumizyme 49 RELISTOR 49 teduglutide 49 Drug Administration FDA 49 ISENTRESS 49 Hycamtin 49 ATryn R 49 Invega 49 alogliptin 49 Gilenia 49 prescribers 49 QNEXA 49 Trexima 49 Drug Application 49 CDER 49 Marketing Authorization Application 49 Invirase 49 Kuvan 49 Bepreve 49 VPRIV 49 VIMOVO 49 OLEPTRO TM 49 PDUFA date 48 GEM #S 48 MONOVISC 48 JZP 6 48 diabetic neuropathic pain 48 Glumetza 48 Rhucin ® 48 Cladribine 48 pediatric exclusivity 48 Metabolic Drugs Advisory 48 Prescribers 48 prGCD