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(Click for frequent words.) 70 Human Use CHMP 70 CHMP opinion 70 European Medicines Agency 70 CHMP recommendation 69 Medicinal Products 67 European Medicines Evaluation 65 Human Medicinal Products 63 Orphan Medicinal Products 62 Medicinal Products EMEA 61 Nebido 61 Proprietary Medicinal Products CPMP 61 Metabolic Drugs Advisory 60 Centralized Procedure 60 Oncologic Drugs Advisory 60 approvable letters 60 orphan designation 60 ezogabine 60 FDA Oncologic Drugs 60 FDA approvable letter 59 orphan medicinal product 59 Marketing Authorization Application 59 Tyverb 59 OMP designation 59 EFSA 59 VPRIV 58 Orphan Medicinal Product 58 Marketing Authorisation 58 ONGLYZA ™ 58 alvimopan 58 NEBIDO 58 Complete Response letter 58 Marketing Authorisation Application 58 Ruconest 58 Torisel 58 Prexige 58 approvable letter 58 Junovan 57 Focetria 57 Marketing Authorization 57 FDA Approvable Letter 57 Marketing Authorization Application MAA 57 TEMODAL 57 Rasilez HCT 57 FDA Advisory Panel 57 Trobalt 57 FIRAZYR 57 approvability 57 FIRMAGON R 57 Esbriet pirfenidone 57 Dacogen injection 57 Swissmedic 57 Esbriet 57 Aclasta 56 Pixuvri 56 NOXAFIL 56 Increlex R 56 Seroquel XR 56 MAA submission 56 CPMP 56 Adenuric R 56 Xyrem ® 56 Safety Authority EFSA 56 BLA submission 56 Certican 56 Raptiva R 56 Ceplene R 56 Romiplostim 56 Rhucin ® 56 Replagal 56 Cladribine 56 Zenpep 55 Zalbin 55 Onsolis 55 Clolar 55 Avastin bevacizumab 55 Exforge HCT 55 Egrifta 55 Arthritis Advisory 55 Onrigin 55 FDA Endocrinologic 55 Ilaris 55 bazedoxifene 55 FDA Complete Response 55 Plicera 55 Orathecin 55 PhosLo 55 Saphris 55 Multaq R 55 Teysuno 55 Drug Administration Oncologic Drugs 55 Neupro ® 55 Neupro R 55 SCHWARZ PHARMA 55 Final Appraisal Determination 55 Rasilamlo 55 oral ridaforolimus 55 eprodisate KIACTA TM 55 Biologics Licensing 55 Neupro 55 CONBRIZA 55 Rhucin 55 Decentralized Procedure 55 Sycrest 54 FDA 54 Mircera 54 Esbriet ® 54 indacaterol 54 Auxilium Pharma 54 FDA Dermatologic 54 Alitretinoin 54 Toctino R 54 Jevtana 54 IRESSA 54 Ceplene 54 Raptiva ® 54 Marketing Authorization Applications 54 Complete Response Letter 54 PROMACTA 54 Tasigna nilotinib 54 velaglucerase alfa 54 vandetanib 54 sNDA 54 Joulferon 54 Positive Opinion 54 FDA Anti Infective 54 Kynapid 54 Fampyra 54 Promacta 54 Tygacil 54 Lorqess 54 Zavesca 54 Complete Response 54 L MTP PE 54 tocilizumab 54 octreotide implant 54 prucalopride 54 pirfenidone 54 efalizumab 54 Mimpara 54 DCGI 54 Pirfenidone 54 roflumilast 54 Scientific Advice 54 Vernakalant 54 mifamurtide 54 amifampridine phosphate 53 PREOS 53 BLA filing 53 Biologic License Application BLA 53 AZILECT R 53 Movectro 53 PDUFA date 53 Bronchitol 53 Voraxaze 53 Angiox 53 Preotact 53 Retacrit 53 Toctino ® 53 FDA Antiviral Drugs 53 MEPACT 53 SEBIVO 53 Lambert Eaton Myasthenic 53 Vasovist 53 Cimzia ® 53 Tekturna HCT 53 Celgene Revlimid 53 Ranolazine 53 Orphan Drug Designation 53 Trexima 53 Nabi HB Intravenous 53 Anti Infective Drugs 53 Humenza 53 Amyvid 53 Pegintron 53 Cimzia 53 Galvus 53 orphan medicinal 53 Pulmonary Allergy Drugs 53 aztreonam lysine 53 NASDAQ Hearings Panel 53 ARCOXIA 53 Reclast Aclasta 53 Fablyn 53 MabCampath 53 Noxafil 53 Antiviral Drugs Advisory 53 SPIRIVA HandiHaler 53 Removab 53 NOMAC E2 53 DORIBAX 53 PegIntron 53 Androxal ® 53 metoprolol succinate 53 Toctino ® alitretinoin 53 Renal Drugs Advisory 53 Exforge 53 RoActemra 53 vinflunine 53 Viviant 53 Intermezzo ® NDA 53 interferon gamma 1b 53 azficel T 53 motavizumab 53 Firdapse ™ amifampridine phosphate 52 USFDA 52 Tredaptive 52 Orphan Drug status 52 Calcium Acetate 52 peginesatide 52 sBLA 52 Emselex 52 REVLIMID lenalidomide 52 guanfacine extended release 52 Evoltra 52 Application MAA 52 desvenlafaxine 52 Revolade 52 Gilenia 52 Somatuline R Autogel R 52 EMEND 52 ELAPRASE 52 FDA Pulmonary Allergy 52 Endocrinologic 52 Stavzor 52 Doribax 52 Marketing Authorisation Application MAA 52 Afinitor ® 52 Ruconest ™ 52 ONGLYZA 52 TYKERB 52 Oracea ® 52 Thalidomide Pharmion 52 Entereg 52 Onbrez Breezhaler 52 Firazyr 52 pralatrexate 52 eltrombopag 52 Mutual Recognition Procedure 52 Potiga 52 ACOMPLIA R 52 lasofoxifene 52 Vpriv 52 Cancidas 52 Hycamtin 52 Multaq 52 Protopic 52 ATryn 52 Votrient 52 Mepact 52 Fabry Disease 52 PRISTIQ 52 CIP TRAMADOL ER 52 paliperidone palmitate 52 Fast Track Status 52 Arzerra 52 AZILECT ® 52 aflibercept 52 Emezine 52 Risperidone Oral Solution 52 Taxotere ® 52 Ocrelizumab 52 Angiox ® 52 FDA Psychopharmacologic Drugs 52 rilonacept 52 CELVAPAN H#N# 52 Febuxostat 52 Nexavar sorafenib 52 Drug Administration FDA Oncologic 52 balsalazide tablet 52 Luveris 52 Kuvan 52 Icatibant 52 Xinlay 52 PRIALT 52 Thyrogen 52 Proprietary Medicinal Products 52 Vimpat R 52 taliglucerase alfa 52 EXALGO 52 sNDA submission 52 Ixempra 52 PDUFA Date 52 Hearings Panel 52 OPAXIO 52 Brilique 52 Approvable Letter 51 Revlimid lenalidomide 51 rotigotine transdermal patch 51 STELARA TM 51 Satraplatin 51 investigational antiplatelet agent 51 Exalgo 51 BENLYSTA 51 Adalimumab 51 SUTENT ® 51 Cerepro 51 Ophthalmic Drugs Advisory 51 Product Characteristics 51 albinterferon alfa 2b 51 Complete Response Letter CRL 51 Focalin XR 51 Board DSMB 51 QNEXA 51 Keppra ® 51 #D#C# 51 Keppra ® levetiracetam 51 Psychopharmacologic Drugs Advisory 51 Uplyso 51 Vectibix panitumumab 51 Keppra ® XR 51 Afrezza 51 oxymorphone ER 51 Ferinject 51 WILEX 51 Vimpat 51 Advagraf 51 dalbavancin 51 Actemra 51 ATPace TM 51 Dynastat 51 Plenaxis R 51 Omnitrope 51 Relistor 51 Eloxatin ® 51 Lilly Cymbalta 51 CAELYX 51 SPARLON 51 maraviroc 51 Myozyme 51 ONTAK 51 Sebivo 51 Clolar ® 51 Zolpimist 51 Telzir 51 abatacept Orencia 51 Glybera R 51 SmPC 51 Hexvix 51 Vandetanib 51 AFSSAPS 51 FRDA 51 Research CDER 51 Orphan Designation 51 ECVAM 51 Advair Diskus 51 Civacir 51 VYVANSE 51 Xarelto 51 FTY# 51 RoACTEMRA 51 Sanvar R 51 BYDUREON 51 Accelerated Approval 51 Drug Administration FDA 51 Celebrex celecoxib 51 QAB# 51 YAZ ® 51 somatropin 51 Cinryze 51 abatacept 51 Mylotarg 51 Cerepro ® 51 Rhucin R 51 liprotamase 51 Alimta pemetrexed 51 Soliris TM eculizumab 51 Vidaza azacitidine 51 Ambrisentan 51 Soriatane 51 THELIN 51 EFSA Panel 51 Daxas 51 Aflunov 51 lorcaserin NDA 51 Ticagrelor 51 SYCREST 51 alogliptin 51 SNT MC# 51 Drugs Advisory 51 ZOLINZA 51 Bonefos 51 FACTIVE R gemifloxacin 51 UPLYSO 51 XYZAL ® 51 Receives Positive Opinion 51 Drug Administration FDA Endocrinologic 51 prGCD 51 Tracleer r 51 MHRA 51 Dendreon Provenge 51 indiplon capsules 51 Frova ® 51 Lumizyme 51 Keppra XR 51 Tysabri natalizumab 51 BRILINTA 51 Yondelis 51 Nplate 50 TRISENOX 50 CDER 50 Biologic License Application 50 Horizant 50 BYETTA ® 50 rasagiline tablets 50 Orphan Status 50 Tindamax 50 Cellegesic 50 ELIQUIS 50 TORISEL TM 50 Sutent sunitinib 50 SEROQUEL XR 50 BioMarin Pharma 50 subcutaneously administered 50 REVLIMID R 50 ORENCIA ® 50 orBec 50 Berinert 50 ORENCIA R 50 Biologics License Application 50 EVICEL 50 Biologics License Application BLA 50 GTC recombinant form 50 Evicel 50 Saforis 50 methylnaltrexone 50 JANUVIA 50 REMICADE ® 50 Krystexxa 50 Drug Administration USFDA 50 Pulminiq 50 Arranon 50 ULTRASE 50 Adenuric 50 JOULFERON 50 Sular formulation 50 Bydureon 50 MabThera rituximab 50 Orphan Drug Status 50 Sparlon 50 trabectedin 50 Darunavir 50 Medicines Consortium 50 Teriparatide 50 Fludara ® 50 romiplostim 50 Sandostatin LAR 50 ZEFTERA TM 50 Cimzia certolizumab pegol 50 Lodotra 50 Roflumilast 50 NASDAQ Listing Qualification 50 Forsteo 50 ANTEGREN 50 Clevudine 50 PROCRIT 50 Intuniv 50 Metabolic Drugs 50 Coadministration 50 Cimzia ® certolizumab pegol 50 eprodisate Fibrillex TM 50 Loramyc 50 aztreonam 50 Photocure 50 Epoetin alfa 50 Clofarabine 50 anidulafungin 50 Bepreve 50 Victoza 50 octagam ® 50 Golimumab 50 Zyflo CR 50 Pfizer Sutent 50 Pennsaid R 50 Cimzia R 50 generation purine nucleoside 50 Orexigen Contrave 50 ACCLAIM II 50 Mycamine 50 Natroba 50 Onrigin TM 50 Extavia 50 Entocort 50 Increlex ® 50 COMFORT II 50 Ciclesonide 50 AstraZeneca Symbicort 50 USFDA approval 50 EGRIFTA ™ 50 supplemental Biologics License Application 50 Rasagiline 50 EGRIFTA TM 50 Release Capsules 50 Ropinirole 50 ONSOLIS 50 Canvaxin 50 Adentri 50 ATryn R 50 Synvisc One 50 RANK Ligand inhibitor 50 5mg #mg #mg 50 Actimmune R 50 SUCCEED trial 50 Aviptadil 50 Belimumab 50 Santhera 50 Citizen Petition 50 oral iron chelator 50 Linjeta 50 Fanapt TM 50 REBETOL combination therapy 50 Afinitor 50 Nasdaq Hearings Panel 50 Evoltra TM 50 Myfortic 50 ZEGERID Capsules 50 Vimovo 50 Angiox R 50 Flutiform TM 50 Velcade bortezomib 50 Alvesco R 50 Aurexis 50 TachoSil 50 Patanase 50 Fortigel 50 Kepivance 50 TYGACIL 50 Glybera 50 APF# 50 Orapred ODT 50 Tarceva TM 50 GALNS 50 Arixtra 50 New Drug Application 50 vismodegib 50 Telavancin 50 EMBEDA ™ 50 XIAPEX 50 Tekamlo 50 DASISION study 50 Ranexa 50 Adenuric ® 50 Exelon rivastigmine 50 AERIUS 50 PhotoCure 50 Bifeprunox 50 OMAPRO ™ 50 Gene Therapy Advisory 49 Serdolect ® 49 Fibrillex TM 49 Clinuvel 49 XIAFLEX ™ 49 fluvoxamine maleate 49 Nivestim 49 THALOMID R 49 XGEVA 49 Zytiga 49 Sumavel DosePro 49 Adventrx 49 ustekinumab 49 application sNDA 49 Peginterferon alfa 2b 49 Receives Marketing Authorization 49 ANDA submission 49 Somatuline Depot 49 Alvesco 49 Orencia abatacept 49 Schweizerhall 49 Certriad 49 pancreatic enzyme replacement 49 GATTEX TM 49 REYATAZ R 49 Xgeva 49 Application BLA 49 Victoza liraglutide 49 Roche Actemra 49 Tracleer R 49 Orphan Drug designation 49 Amrubicin 49 YERVOY 49 Daytrana ® 49 tramiprosate ALZHEMED TM 49 Vectibix 49 Dalbavancin 49 Ixabepilone 49 oral cladribine 49 HFA MDI 49 Zimulti 49 QVAR ® 49 GTC recombinant human 49 REPLAGAL 49 Zebinix R 49 Naglazyme 49 Injectafer 49 Betaferon 49 Desvenlafaxine 49 Exanta 49 Fodosine 49 Simulect 49 AVANDIA 49 donepezil rivastigmine 49 Riluzole 49 Approvable 49 Azathioprine 49 Basilea Toctino R 49 Multaq dronedarone 49 Amigal 49 Fortical R 49 Product Monograph 49 Ilaris ® 49 Regeneron Pharma 49 darifenacin 49 Sanctura XR 49 Actemra tocilizumab 49 Zavesca R 49 Vimpat ® lacosamide 49 Preotact R 49 PCV# 49 Eucreas 49 MAGE A3 ASCI 49 FENTORA 49 Vertex telaprevir 49 Anastrozole 49 Fosrenol 49 oral alitretinoin 49 Prexige lumiracoxib 49 Sutent sunitinib malate 49 ceftobiprole 49 PROCRIT ® 49 Resolor 49 Ozurdex 49 Stelara 49 IV acetaminophen 49 exocrine pancreatic insufficiency 49 BioDelivery Sciences 49 Adcirca 49 Tekturna HCT ® 49 mesylate tablets 49 PROVENGE ® 49 lucinactant 49 hylan GF 49 capsule formulation 49 NDA submission 49 Xarelto rivaroxaban 49 FDA Oncologic Drug 49 PREZISTA 49 Vion Pharmaceuticals 49 Oral Solution 49 Vimpat lacosamide 49 atypical antipsychotic medication 49 Syndrome LEMS 49 Ramelteon 49 Jerini 49 RhuDex 49 Mirapexin 49 Uloric 49 ketolide antibiotic 49 Candesartan 49 Known hypersensitivity 49 Cinryze TM 49 Xyzal 49 testosterone gel LibiGel 49 muraglitazar 49 Evoltra ® 49 Bayer Xarelto 49 Not Approvable 49 Alvesco ® 49 Arxxant 49 aleglitazar 49 Zarnestra 49 CDP# 49 Rebetol 49 Provenge prostate cancer 49 pediatric exclusivity 49 CAPHOSOL 49 Spiriva HandiHaler 49 PrandiMet 49 BfArM 49 Herceptin trastuzumab 49 Novartis Prexige 49 Cellcept 49 Diamyd r 49 TYZEKA 49 aripiprazole Abilify 49 Troxatyl 49 PrevOnco 49 MYLOTARG 49 Orazol 49 histamine dihydrochloride 49 WHO prequalification 49 severe hypercholesterolemia 49 Drug Submission 49 Announces Tentative Approval 49 Long Term Efficacy 49 Elidel 49 CryoSeal FS System 49 PLAVIX ® 49 Tasigna 49 HepaGam B TM 49 Torisel temsirolimus 49 Tesamorelin 49 TroVax 49 Dynepo 49 LIALDA 49 Frova R 49 human antithrombin 49 Silenor NDA 49 Tyvaso 49 Relovair 49 SILENOR 49 Neurodex 49 Drug Eluting Stent System 49 injectable formulations 49 liver resection surgeries 49 Toctino 49 Vyvanse lisdexamfetamine dimesylate 49 Keryx Biopharma 49 Pre IND 48 Ventavis 48 BARACLUDE R 48 Pemetrexed 48 febuxostat 48 ADVEXIN 48 Gaucher Disease 48 eprotirome 48 Plenaxis TM 48 Extended Release Capsules 48 Toviaz 48 Velaglucerase Alfa 48 BLP# Liposome Vaccine 48 Fortovase 48 FDA Accepts 48 Zirgan 48 orphan drug 48 SILENOR TM 48 Trovax 48 QAB# indacaterol 48 Ceflatonin 48 Arzerra TM 48 Dyloject TM 48 Arzerra ofatumumab 48 Abiraterone acetate 48 Barr ANDA 48 Bridion 48 EDQM 48 TWYNSTA ® 48 Aztreonam Lysine 48 TAXUS Element Stent System 48 Prezista 48 Kiacta 48 pharmacokinetic studies 48 Tablets #mg [001] 48 EGRIFTA 48 Tezampanel 48 Pentacel vaccine 48 oral rivaroxaban 48 Phase III clinical 48 cangrelor 48 FOSRENOL 48 Japanese Encephalitis vaccine 48 Fanapt 48 Taxotere docetaxel 48 sunitinib malate 48 Orphan designation 48 AVASTIN 48 Sodium Injection 48 Paragraph IV Notice 48 fingolimod 48 Phase III Clinical Trial 48 Estratest 48 ACTEMRA TM 48 Privigen 48 NeoRecormon 48 Femara letrozole 48 Spiriva Handihaler 48 Sprycel dasatinib 48 Priority Review 48 nasal calcitonin product 48 Velac 48 Sanvar 48 Transkaryotic 48 1mg 2mg 48 pazopanib 48 Kamada AAT 48 Vivus Qnexa 48 Revlimid 48 Zelrix 48 brivaracetam 48 pegloticase 48 markets HP Acthar 48 adalimumab Humira 48 XGEVA ™ 48 Serdolect 48 Lenalidomide 48 supplemental biologics 48 Loramyc ® 48 Mycograb 48 Expanded Indication 48 Emend 48 solifenacin succinate 48 Amlodipine Besylate 48 Diamyd ® 48 Vibativ 48 Aridol 48 CERVARIX 48 Metformin Hydrochloride 48 Nuedexta 48 asenapine 48 FASLODEX 48 Rapaflo 48 Chief Executive Matthew Emmens 48 phase IIb trial 48 midodrine 48 LibiGel ® 48 Betaferon R 48 Cefprozil 48 registrational 48 Renvela 48 Combunox 48 Sanofi aventis EURONEXT SAN 48 Boxed Warning 48 ISTODAX 48 Fast Track Designation 48 ulipristal acetate 48 Afinitor everolimus 48 FDA Accelerated Approval 48 Dr. Gulfo 48 sapropterin dihydrochloride 48 REYATAZ 48 Tibotec Pharmaceuticals Ltd. 48 GLP toxicology studies 48 Increlex 48 Dacogen 48 Zactima 48 clopidogrel bisulfate 48 sublingual tablets 48 Liprotamase 48 Ruconest TM 48 LUVENIQ 48 Starlix 48 FDAs 48 Azilect ® 48 Amlodipine Besylate Tablets 48 Eraxis 48 Amgen Vectibix 48 Modrenal R 48 Loramyc R 48 Bazedoxifene 48 sitaxsentan sodium 48 Nonprescription Drugs Advisory 48 ARIXTRA R 48 SANVAR 48 injectable antibiotic 48 Sanofi Acomplia 48 casopitant 48 Onglyza 48 Pliaglis 48 recombinant thrombin 48 Zelnorm Zelmac 48 Pegloticase 48 tramadol HCl 48 Durolane 48 Omnitarg 48 JECFA 48 FDA Nonprescription Drugs 48 Voraxaze ™ 48 methylnaltrexone bromide 48 Cenestin 48 Altabax 48 anti arrhythmic 48 Protelos 48 Rezonic 48 SIR Spheres 48 Pennsaid 48 Prestara 48 Terbinafine 48 Clinical Trial Application 48 Market Authorization Application 48 RIGScan CR 48 DYSPORT TM 48 VIAject 48 Zyflo 48 Surfaxin lucinactant 48 Yondelis ® 48 Pivotal Phase III 48 Hydrochlorothiazide 48 SNT-MC#/idebenone 48 TroVax ® 48 Abstral 48 refractory chronic lymphocytic 48 Zenvia 48 Rapydan 48 Ranexa R 48 Shire BioChem Inc. 48 Zerenex 48 Azacitidine 48 frovatriptan 48 Merck Arcoxia 48 Combidex 48 QLT# 48 NUVIGIL 48 Dabigatran etexilate 48 bifeprunox 48 octreotide acetate 48 SinuNase TM 48 Phase IIB 48 Riquent 48 Fast Track designation 48 Mitigation Strategy REMS 48 CoFactor 48 Ferumoxytol 48 Boceprevir 48 Elitek 48 Dexilant 48 Zevtera 48 SPRIX ® 48 Immunisation Practices 48 Ziprasidone 48 PIX# trial 48 Reloxin R 48 Tykerb 48 Dasatinib 48 telavancin NDA 48 rosiglitazone 48 darbepoetin alfa Aranesp 47 Genzyme Synvisc 47 chronic idiopathic thrombocytopenic purpura 47 investigational compound 47 CERVARIX R 47 DexaSite 47 ALVESCO R 47 Zingo TM 47 Centralised Procedure 47 bioequivalence 47 Impax ANDA 47 Corlux 47 mesylate 47 TORISEL 47 CRMD# 47 SPRYCEL ® 47 Pazopanib 47 Rasilez Tekturna 47 capsules USP 47 Decentralized Procedure DCP 47 clofarabine 47 INSPIRE Trial Phase III 47 Certolizumab pegol 47 Zorbtive TM 47 cetuximab Erbitux 47 Ofirmev 47 post operative ileus 47 Cethromycin 47 Aptivus 47 senicapoc 47 Thalomid 47 cervical cancer vaccine Cervarix 47 AMITIZA R 47 Cladribine Tablets 47 NDA resubmission 47 HCl capsules 47 pemoline 47 Allergies NDA 47 INVEGA ® 47 Glatiramer Acetate 47 ATACAND 47 Rotarix ® 47 MICARDIS 47 levetiracetam Keppra 47 AstraZeneca Toprol XL 47 Fast Track designations 47 Saquinavir 47 fidaxomicin 47 PROVIGIL 47 CNTO 47 chronic angina 47 MERREM 47 SEASONALE 47 AMRIX 47 cladribine 47 FluLaval 47 Synthon 47 Arcalyst 47 panitumumab Vectibix 47 Sanofi Aventis Taxotere 47 Sibutramine Cardiovascular Outcomes 47 INCIVEK 47 ANDA filer 47 IXEMPRA 47 granulated mesalamine 47 Gestiva 47 Afluria 47 Chemicals Agency ECHA 47 ONGLYZA TM 47 THALOMID 47 Valtropin 47 carcinogenicity studies 47 Veregen TM 47 TSX SHQ 47 cinacalcet 47 Phase Ib study