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(Click for frequent words.) 64 Mitigation Strategy REMS 63 Risk Evaluation 58 EXALGO 58 RiskMAP 57 Medication Guide 57 QbD 56 Mitigation Strategy 55 FDAAA 54 postapproval 54 MDUFMA 53 MAA submission 53 prescribers 53 Extavia 53 CDER 53 Frova ® 53 Icatibant 53 MoxDuo IR 52 ESA APPRISE Oncology 52 propoxyphene containing 52 Onsolis 52 TOPROL XL 52 NDA resubmission 52 Mitigation Strategies REMS 52 pharmacotherapies 52 alvimopan 52 TOUCH Prescribing Program 52 Preotact 51 ZEGERID Capsules 51 pharmacovigilance 51 postmarketing surveillance 51 CCRx 51 Limbrel 51 EMBEDA 51 Invega 51 BiDil XR 51 ezogabine 51 Vimpat R 51 Xyrem ® 51 Drug Administration Amendments 51 Exalgo 51 FDA Modernization Act 51 SILENOR 50 Combunox 50 naproxen esomeprazole magnesium 50 eMDR 50 PROVIGIL 50 Surfaxin LS 50 Asmanex 50 Voraxaze 50 EMBEDA ™ 50 Orapred ODT 50 XOPENEX 50 Focalin XR 50 Genzyme Myozyme 50 Dexilant 50 PDUFA Prescription Drug 50 eCTD format 50 SURFAXIN 50 desvenlafaxine 50 guanfacine extended release 50 Zolpimist 50 HCl capsules 50 Ropinirole 50 XIAFLEX ™ 50 FENTORA 50 sNDA submission 50 INCIVEK 50 Trobalt 50 Emend 50 systemic immunosuppressive drugs 50 PDUFA 50 TNF alpha inhibitor 50 McNeil Pediatrics 50 COX 2s 49 Subpart H 49 DDMAC 49 Symbyax 49 BRILINTA 49 Effient prasugrel 49 Foradil Aerolizer 49 Spiriva HandiHaler 49 DYSPORT TM 49 IV acetaminophen 49 FACTIVE tablets 49 Firazyr 49 MGCD# clinical trials 49 NitroMist 49 Expedited Review 49 Viibryd 49 Prescriber 49 topiramate Topamax 49 BLA filing 49 LDTs 49 PRISTIQ 49 InfoMedics 49 Med eMonitor System 49 PDUFA date 49 Horizant 49 Erythropoiesis Stimulating Agents ESAs 49 oxymorphone ER 49 fluvoxamine maleate 49 Glycopyrrolate 49 SANVAR 49 Boxed Warning 49 Sycrest 49 Gralise 49 Ramelteon 49 Zyflo CR 49 Frova 49 Zelapar 49 EpiPen Auto Injector 49 aripiprazole Abilify 49 levalbuterol 49 Chronic Obstructive Lung 48 CAELYX 48 NASPER 48 AstraZeneca Symbicort 48 injectable formulations 48 INVEGA SUSTENNA 48 RIGScan CR 48 Centralized Procedure 48 Botox Botox Cosmetic 48 Noxafil 48 Entereg 48 Acthar Gel 48 ARIXTRA R 48 Natroba 48 Zenpep 48 DoseEdge 48 ONSOLIS 48 Vilazodone 48 Risperdal Zyprexa 48 CONTRAINDICATIONS 48 visit www.BYETTA.com 48 stepwise approach 48 Colcrys 48 Treximet 48 Plenaxis R 48 ZOLINZA 48 FDA 48 mg Tablets 48 PDUFA Date 48 Emezine 48 Biosimilars 48 MedSmart 48 Zipsor 48 Egrifta 48 Arixtra ® 48 granisetron formulated 48 PROMETA ® 48 ISENTRESS 48 Metozolv ODT 48 FDAs 48 Gilenia 48 divalproex sodium 48 atypical anti psychotics 48 Accelerated Approval 48 treat GI GVHD 48 NDA submission 47 Product Characteristics 47 Medication Therapy Management 47 sterile compounding 47 dorzolamide 47 SEASONALE 47 Zelrix 47 FDA Psychopharmacologic Drugs 47 Priority Review 47 Lilly Cymbalta 47 NeutroSpec 47 orally disintegrating 47 FLECTOR ® Patch 47 Prescribers 47 OROS R Hydromorphone 47 Celebrex celecoxib 47 casopitant 47 AHFS 47 postmarket surveillance 47 Trexima 47 Frova R 47 Diastat 47 Premarket Approval PMA 47 CFATS 47 LibiGel ® 47 ACUROX ® 47 AVONEX PEN 47 User Fee Act 47 balsalazide tablet 47 BESST 47 Kombiglyze XR 47 approvability 47 THALOMID 47 ADDERALL XR 47 FDA Accelerated Approval 47 Potiga 47 Bristol Myers Squibb Abilify 47 FDA approvable letter 47 Ofirmev 47 Certriad 47 Flolan 47 Ultracet R 47 Postmarket 47 Cladribine 47 FACTIVE R gemifloxacin 47 SYCREST 47 ESAs 47 AZILECT R 47 INTELENCE 47 Qualaquin 47 Ticagrelor 47 Research CDER 47 psychopharmacological 47 DOSAGE AND ADMINISTRATION 47 CryoSeal FS System 47 Act PDUFA 47 ICH E# 47 Protopic 47 Sporanox 47 Mycophenolate Mofetil 46 Telavancin 46 Vivus Qnexa 46 Exforge HCT 46 indiplon capsules 46 Pentacel vaccine 46 SPARLON 46 metoprolol succinate 46 CYCLOSET 46 CERVARIX R 46 Aquoral TM 46 PMAS 46 Heparin Sodium 46 Toctino ® alitretinoin 46 UCB Keppra 46 biogenerics 46 Generic Versions 46 Torisel 46 Morphine Sulfate 46 Tygacil 46 therapeutically equivalent 46 Carbatrol 46 Exelbine NDA 46 eprodisate Fibrillex TM 46 T Pred 46 Advair Diskus 46 Generic Version Of 46 premarket notification 46 Pfizer Lyrica 46 Script IQ 46 Prescription Drug User Fee 46 APhA 46 venlafaxine HCl 46 Seroquel XR 46 POSIDUR TM 46 topical NSAID 46 Devices Advisory Panel 46 METOZOLV ODT 46 NHIN Direct 46 Copay 46 Viviant 46 AstraZeneca Toprol XL 46 Tredaptive 46 clopidogrel bisulfate 46 Prescribing Information 46 XOPENEX Inhalation Solution 46 Effexor venlafaxine 46 generic biologic 46 ORADUR ADHD 46 biosimilar 46 AdreView 46 Complete Response 46 COSO framework 46 Marketing Authorisation Application 46 BLA submission 46 Stelara 46 Q#IR 46 PDRP 46 Biologics Licensing 46 PGx 46 Ralivia TM 46 FDA Approvable Letter 46 Equetro 46 Keflex 46 eCTD submissions 46 ENTEREG 46 Electronic Prescribing 46 formulary 46 CWMP 46 faropenem 46 Animi 3 46 Lorqess 46 Clintrace 46 Montelukast 46 DNAwithPap TM Test 46 APF# NDA 46 eSubmissions 46 Invirase saquinavir 46 Stavzor 46 Nesiritide 46 CB1 antagonists 46 prescribers pharmacists 46 Cellegesic 46 equivalent Reglan 46 GRANISOL 46 postmarketing 46 Caduet 46 Pirfenidone 46 Pixuvri 46 Meaningful Use requirements 46 Novartis AG Foradil 46 ACC AHA ESC 46 Benazepril 45 TNF blocker 45 Retacrit 45 PhosLo 45 levetiracetam Keppra 45 MEVACOR 45 Mitigation Strategies 45 risedronate sodium tablets 45 Wellbutrin bupropion 45 Clozaril 45 Bifeprunox 45 Amnesteem 45 Pfizer Geodon 45 Lidoderm patch 45 Afrezza 45 Oral Solution 45 Inhaled Insulin 45 Specification PAS 45 IV admixture 45 Xifaxan 45 Accountable Care 45 NOXAFIL 45 Fortical R 45 biologic DMARDs 45 Disease GOLD 45 pharmacoeconomic 45 SPIRIVA HandiHaler 45 biogeneric drugs 45 VIPPS accreditation 45 Somatuline R Autogel R 45 CDRH 45 GRALISE 45 Nebido 45 Visicol 45 AMEVIVE 45 Arranon 45 Zegerid OTC 45 RoHS Compliance 45 Bepreve 45 PASS Rx 45 OLEPTRO 45 Zytiga 45 Ranexa 45 Earned Value 45 Abilify aripiprazole 45 Symlin 45 Aplenzin 45 MEDMARX 45 Mepact 45 TRADJENTA 45 MoviPrep 45 LensAR Laser System 45 Rapaflo 45 SILENOR ™ 45 Sanctura XR 45 Altabax 45 Zyflo 45 OsmoPrep 45 Eli Lilly Cymbalta 45 approvable letters 45 VBID 45 nephrotic syndrome NS 45 BioDelivery Sciences 45 BeneFIX 45 Keppra ® levetiracetam 45 Velcade bortezomib 45 non selective NSAIDs 45 Posaconazole 45 MEND CABG II 45 ustekinumab 45 PRADAXA 45 Biologics License Application BLA 45 Octreolin 45 JANUMET 45 Acurox 45 Full Prescribing Information 45 capsule formulation 45 Genz # 45 NCCN Drugs 45 candidates Dyloject TM 45 Pre IND 45 biogeneric 45 Xarelto rivaroxaban 45 Bydureon 45 Aptivus 45 overthe counter 45 FDA Endocrinologic 45 REMINYL ® 45 Relistor 45 dalbavancin 45 CIP TRAMADOL ER 45 PDE4 inhibitors 45 Sanofi Acomplia 45 Ralivia 44 daptomycin 44 NCCN guidelines 44 antimicrobial stewardship 44 Carbidopa Levodopa 44 PRECISE Trial 44 pioglitazone Actos 44 Junovan 44 MMSEA 44 loratadine 44 DYSPORT 44 atypical antipsychotic medication 44 prefilled syringe 44 Krystexxa 44 IND submission 44 Adcirca 44 Nuedexta 44 COLAZAL 44 CHMP 44 Trizivir 44 DORIBAX 44 Dacogen injection 44 full Prescribing Information 44 FALCPA 44 PrandiMet 44 Merck Januvia 44 AstraZeneca Toprol 44 Amgen Aranesp 44 Fentora 44 Zalbin 44 Cethromycin 44 RxNorm 44 proton pump inhibitors PPIs 44 Standards Consortium CDISC 44 EpicCare 44 Formularies 44 Generic Version 44 omeprazole Prilosec 44 Hydromorphone 44 sertraline Zoloft 44 Corlux 44 molecular entities NMEs 44 Suprax 44 ONCHIT 44 darbepoetin alfa Aranesp 44 CPTR 44 CDISC standards 44 Lilly Zyprexa 44 Xanodyne 44 Anzemet 44 Nonprescription 44 ARRA HITECH 44 prescription dermatological 44 European Medicines Evaluation 44 Pulmonary Allergy Drugs 44 MDDS 44 Novartis Galvus 44 Dr. Gulfo 44 Psychopharmacologic Drugs Advisory 44 ARCOXIA 44 CriticalPoint 44 Aloxi Injection 44 Deferiprone 44 Orphan Status 44 Contrave 44 Bazedoxifene 44 FDA reviewers 44 DMEPOS supplier 44 QNEXA 44 Veeva CRM 44 InterQual 44 Xinlay 44 Depakote ER 44 erythropoietin stimulating agents 44 Ixempra 44 eprescribing 44 PMA submission 44 ISMP 44 Metabolic Drugs Advisory 44 Cesamet 44 escitalopram oxalate 44 Anti Infective Drugs 44 medication adherence 44 Inhaled insulin 44 Rythmol SR 44 ULTRASE 44 SNOMED 44 Rx Response 44 Indiplon 44 lorcaserin NDA 44 renal toxicity 44 APhA Foundation 44 DrFirst Rcopia 44 Strativa 44 compendia 44 Vandetanib 44 Intermezzo ® NDA 44 Certican 44 contra indications 44 Synavive ™ 44 Solstice Neurosciences 44 FDAâ € ™ 44 Sumatriptan Succinate 44 Granisetron 44 Innovent Oncology 44 Lidoderm ® 44 ePrescribing 43 MYCAMINE 43 caBIG ® 43 FOSAMAX PLUS D 43 FDA Complete Response 43 enoxaparin sodium injection 43 Mycamine 43 Byetta LAR 43 Package Insert 43 Implementation Guides 43 Tekturna HCT 43 Regranex 43 tezampanel NGX# 43 Nonprescription Drugs 43 Daliresp 43 MK #B 43 Humira adalimumab 43 Teysuno 43 JPDO 43 Hycamtin 43 Bayer Xarelto 43 generic Copaxone 43 Bioequivalence 43 BOXED WARNING 43 Dendreon Provenge 43 GHTF 43 Glumetza TM 43 Dulera 43 Kynapid 43 Champix varenicline 43 cGMPs 43 ixabepilone 43 nonsedating antihistamine 43 IRESSA 43 heparins 43 #mg #mg #mg #mg [002] 43 Prevacid #HR 43 Spiriva Handihaler 43 Joulferon 43 MedDRA 43 pharmacogenomic testing 43 NextGen EHR 43 Anidulafungin 43 galantamine Reminyl 43 FISMA compliance 43 Palladone 43 Removab 43 Febuxostat 43 postmarket safety 43 buccal tablets 43 Rotarix ® 43 Muraglitazar 43 Intelence 43 generic Prilosec 43 HepaGam B 43 #mg dosage strength 43 Clinger Cohen 43 Serious Side Effects 43 varenicline tartrate 43 Xolair 43 Uloric 43 DPCO 43 Risperidone Oral Solution 43 ACCU BREAK 43 motavizumab 43 Novartis Diovan 43 IntelliDOT BMA 43 ZEGERID Chewable Tablets 43 Tasigna nilotinib 43 FDA Advisory Panel 43 Premarket Approval 43 CigRx TM 43 Accolate 43 OLEPTRO TM 43 Cintredekin besudotox 43 Entocort 43 Comparative Effectiveness Research 43 NMEs 43 Xarelto 43 Prescriptive 43 FDA Accepts 43 Adverse Event Reporting 43 UCB Cimzia 43 Receives Tentative FDA 43 NitroMist TM 43 allergen avoidance 43 orphan medicinal 43 ICH guidelines 43 APTIMA HPV assay 43 FACTIVE 43 Ondansetron 43 Sensipar 43 Targretin capsules 43 Prostate AdenoCarcinoma Treatment 43 ENLIGHT 43 ProEthic 43 Comparative Effectiveness 43 guideline concordant 43 Wellbutrin XL R 43 Pfizer Exubera 43 Cinryze 43 Foradil 43 Victoza 43 Asclera 43 Metabolic Drugs 43 PROTONIX 43 oxycodone OxyContin 43 ALRT 43 pediatric exclusivity 43 Pfizer inhaled insulin 43 CAQH CORE 43 indications contraindications 43 Merck Arcoxia 43 FDA Oncologic Drugs 43 MOXATAG 43 UVIDEM 43 MHPAEA 43 Vidaza azacitidine 43 Plenaxis TM 43 mesylate tablets approved 43 liprotamase 43 sNDA 43 Soriatane 43 eCTD submission 43 NEBIDO 43 Points HACCP 43 alogliptin 43 Kaletra tablet 43 autoinjector 43 heterozygous FH 43 Amgen Epogen 42 Cielo Clinic 42 postmarketing studies 42 REACH 42 Gamunex C 42 Dostinex 42 non sedating antihistamines 42 Receives Approvable Letter 42 PQRI 42 Megace ES 42 clinical endpoints 42 CHMP opinion 42 moxidectin 42 Approvable 42 pravastatin Pravachol 42 Civacir 42 WHO prequalification 42 Reclast Aclasta 42 NCCN Drugs & 42 ASONEP 42 NOPR 42 Vimovo 42 Isotretinoin 42 Prandin 42 antibiotic amoxicillin 42 ValueTrak 42 ZEGERID 42 Oxytrol 42 PRM NGO 42 Bridion 42 XP# XP# 42 Rhucin ® 42 Elestrin TM 42 Plavix clopidogrel 42 Effient 42 Arxxant 42 postmarket studies 42 CareAdvance 42 Wellstat 42 OraTest 42 generic Lovenox 42 RtI 42 FDA Adverse Event 42 Cancidas 42 liver resection surgeries 42 Expanded Indication 42 Biologic License Application BLA 42 bazedoxifene 42 DailyMed ™ 42 HITRUST CSF 42 TWYNSTA 42 pulls Darvon painkiller 42 bioresearch monitoring 42 sNDAs 42 anti arrhythmic 42 oral anticoagulation 42 Wellbutrin SR 42 generic gabapentin 42 prescribing 42 AMPAKINE CX# 42 Qutenza 42 Lipofen 42 DORYX 42 ALTACE 42 Enjuvia 42 Rebetol 42 Relpax 42 Paragraph IV 42 Coreg CR 42 Oncology Drug 42 inpatient EHR 42 Process Analytical 42 Fanapt ® 42 Linjeta 42 PDUFA reauthorization 42 anidulafungin 42 peginesatide 42 Myfortic 42 NCCN Compendium 42 EGRIFTA TM 42 GENERIC SILDENAFIL SOFT Generic 42 CareAdvance Enterprise 42 Fexofenadine 42 antibiotic telavancin 42 Clolar 42 medications 42 JIMO mission 42 Invega Sustenna 42 Warner Chilcott Actonel 42 Surfaxin lucinactant 42 Medicare Modernization Act 42 eRx 42 G3 Guidelines 42 Galvus 42 Cellcept 42 bioequivalent 42 ANDAs 42 URAC Accreditation 42 VALOR trial 42 MOVIPREP 42 ONGLYZA ™ 42 Novartis AG Galvus 42 ONCONASE R 42 guidances 42 Communications DDMAC 42 teratogenicity 42 Ventegra 42 PrimeSUITE 42 outserts 42 Zemplar 42 newer atypical antipsychotic 42 BEXXAR 42 ISPE 42 Rasagiline 42 Alineo 42 FluLaval 42 Oxaliplatin 42 Uroxatral 42 Competence Assurance 42 Sparlon 42 MirixaPro 42 FDA MedWatch 42 Danazol 42 Latuda 42 ARRA Meaningful Use 42 Lotronex 42 Physician Quality 42 midodrine 42 e Prescribe 42 PMA Supplement 42 Extended Producer 42 Silenor NDA 41 Research CBER 41 Biologics Compendium 41 Sular formulation 41 ticagrelor Brilinta 41 LibiGel NDA 41 abacavir containing 41 JCAHO 41 Riluzole 41 Alogliptin 41 prescriber 41 Azathioprine 41 NIST Smart Grid 41 Imitrex Injection 41 depot antipsychotics 41 Ultram ER 41 Entry CPOE 41 Levothyroxine 41 Menaflex implant 41 gadobutrol 41 Omapro 41 Lumizyme 41 TachoSil 41 Weight Loss Drug 41 Mylotarg 41 Cefazolin 41 GRC Governance Risk 41 formularies 41 Telepharmacy 41 Meaningful Use criteria 41 pegfilgrastim 41 precertification 41 repaglinide 41 GoldRx 41 Combating Counterfeit Drugs 41 Endeavor Drug Eluting 41 acid reducer 41 Levothyroxine Sodium 41 OraTest R 41 TransVax tm 41 Orthopedic Advisory Panel 41 Elidel 41 Medi Span ® 41 AVANDIA 41 liver toxicity 41 Tamsulosin 41 Tekamlo 41 nefazodone 41 Devicemakers 41 successfully commercialize Iluvien 41 VBioPharma 41 Onrigin 41 enoxaparin Lovenox 41 alemtuzumab MS 41 Liprotamase 41 CHMP recommendation 41 Complete Response Letter 41 GSK Avandia 41 MedBoard 41 LidoSite 41 Relapse Prevention 41 bendroflumethiazide 41 Amyvid 41 torsemide 41 CORE Phase 41 NCCN Guidelines ™ 41 HITSP 41 Votrient 41 LUVOX CR 41 restarted Knocke 41 Kapidex 41 SAICM 41 postmarket 41 Pfizer Camptosar 41 Interpretative Communication 41 PMPRB 41 Velaglucerase Alfa 41 Aromasin exemestane 41 Pristiq 41 Paxil paroxetine 41 THROMBIN JMI R 41 Actemra 41 Generic Drug 41 Citizen Petition 41 DailyMed TM 41 Megace R 41 Teflaro 41 MedicsDocAssistant 41 Medicinal Products EMEA 41 Pfizer Zithromax 41 OTCs 41 Promacta 41 authority Gurian Sherman 41 GMPs 41 PharmMD 41 Rasilez HCT 41 Primavera P6 41 Lopressor 41 mg usa 41 PIX# trial 41 Estratest 41 Tussionex 41 EHSMS 41 Wyeth Progenics 41 Amgen Prolia 41 Sotret 41 antihormonal 41 SAFECOM 41 Fast Track designations 41 decongestants expectorants antihistamines 41 Attention-Deficit/Hyperactivity Disorder 41 Colazal 41 abacavir sulfate 41 metformin Glucophage 41 Glumetza 41 Neuradiab 41 carotid stent 41 SoluCLENZ Rx Gel 41 Clinical Trials Directive 41 NDAs 41 T SystemEV 41 BioDelivery 41 Factive 41 generic Allegra 41 via intradermal injections 41 OGAC 41 testosterone gel LibiGel 41 empiric therapy 41 mesylate tablets 41 Doribax 41 fluoxetine paroxetine 41 nicardipine 41 InSight Publisher 41 Rimonabant 41 FDA Nonprescription Drugs 41 ESEA reauthorization 41 placebo controlled studies 41 Registration Evaluation Authorisation 41 approvable 41 EVICEL 41 Sunovion 41 Aveed 41 approvable letter 41 Change PGIC 41 Linjeta ™ 41 EC Directives 41 Wellbutrin XL ® 41 Eli Lilly Zyprexa 41 F.D.A. 41 Rilutek 41 DPP4 inhibitor 40 CIP Fenofibrate 40 Bristol Myers Squibb Pravachol 40 Amy Celento 40 LeadCare II 40 Pentasa 40 injectable NSAID 40 #mg Tablets [002] 40 preclinical pharmacokinetic 40 PREVU x LT 40 HCAHPS survey 40 HCPs 40 biostatistical analysis 40 CCHIT certification 40 Supplemental Biologics License Application 40 GelStat Migraine 40 REACH Regulation 40 Fusilev 40 Drug Administration FDA 40 Edurant 40 Thoresen Review 40 Drug Utilization 40 Fingertip Formulary 40 Patanase 40 Pharmacopeial Convention 40 Orexigen Contrave 40 Cleviprex 40 Zavesca 40 granted Ortec 40 PROPEL 40 AstraZeneca Seroquel 40 Amevive 40 Vibativ 40 Velac 40 Afresa 40 Oncologic Drugs Advisory 40 Vertex hepatitis C 40 Neupro 40 rivaroxaban Xarelto 40 Afinitor everolimus 40 Topiramate tablets 40 comitology procedure 40 nonregulatory 40 QOF indicators 40 maker Barr Pharmaceuticals 40 optimal dosing 40 Hylenex 40 Purepac 40 e Prescribing 40 Zemiva TM 40 IPAWS 40 Drug Submission 40 ulipristal acetate 40 GLP GMP 40 MEDCIN 40 MedStart 40 stavudine d4T 40 Propoxyphene 40 Lucrin 40 Fosphenytoin 40 Internal Capital Adequacy 40 k Premarket Notification 40 NOVARTIS 40 Metformin GR 40 donepezil hydrochloride 40 Vitrasert R 40 successfully commercialize Silenor 40 Esbriet 40 Sutent sunitinib malate 40 SVHCs 40 CGMP 40 CORTOSS Bone Augmentation Material 40 Dr. Scangos 40 Neurodex TM 40 cognitive behavioral therapies 40 Orathecin 40 gelcaps 40 Preos 40 CLIRS trial 40 PD VAL