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(Click for frequent words.) 75 CHMP recommendation 70 CHMP 67 Centralized Procedure 67 European Medicines Evaluation 66 Marketing Authorisation 65 MAA submission 65 OMP designation 64 Marketing Authorization 63 orphan designation 63 Marketing Authorization Application 63 Angiox ® 62 Medicinal Products EMEA 62 Adenuric R 62 Marketing Authorization Applications 62 Market Authorization Application 62 Increlex R 62 Marketing Authorization Application MAA 62 Decentralized Procedure 62 TEMODAL 62 Certican 62 Angiox 62 FIRAZYR 61 Rhucin ® 61 orphan medicinal product 61 Marketing Authorisation Application 61 Product Characteristics 61 NEBIDO 61 Tracleer r 61 Focetria 61 European Medicines Agency 61 SmPC 61 FDA approvable letter 61 BLA filing 61 Rhucin R 60 Marketing Authorisation Holders 60 Trobalt 60 Vasovist 60 Orathecin 60 Firazyr 60 SEBIVO 60 CONBRIZA 60 Orphan Drug status 60 Nebido 60 SNT MC# 60 BLA submission 60 WILEX 60 Loramyc R 60 Loramyc ® 60 approvable letters 60 Retacrit 60 FIRMAGON R 59 Thalidomide Pharmion 59 ezogabine 59 Joulferon 59 Teysuno 59 Xyrem ® 59 Toctino R 59 Romiplostim 59 SCHWARZ PHARMA 59 Orphan Medicinal Product 59 Swissmedic 59 Esbriet pirfenidone 59 Ceplene R 59 REBETOL combination therapy 59 Accelerated Assessment 59 Evoltra TM 58 Toctino ® 58 Increlex ® 58 oral ridaforolimus 58 Evoltra 58 Icatibant 58 Somatuline R Autogel R 58 Zenpep 58 Raptiva R 58 Civacir 58 PROVIGIL 58 Zolpimist 58 Voraxaze 58 Torisel 58 Mutual Recognition Procedure 58 SYCREST 58 amifampridine phosphate 58 Replagal 58 Cimzia ® 58 Human Medicinal Products 58 Rasilez HCT 58 Naglazyme 58 Loramyc 58 Application MAA 58 Sycrest 58 Rhucin 58 PROMACTA 57 sNDA submission 57 Ruconest 57 Kiadis Pharma 57 Raptiva ® 57 DRAXIMAGE 57 VPRIV 57 CryoSeal FS System 57 Ceplene 57 AZILECT R 57 Medicinal Products 57 Plenaxis R 57 CUSTOM III 57 Dacogen injection 57 ZOLINZA 57 Human Use CHMP 57 Plicera 57 Tyverb 57 Extavia 57 AZILECT ® 57 THELIN 57 ORENCIA R 57 Neupro R 57 Mimpara 57 Lodotra 57 orphan medicinal 57 Preotact 57 Reclast Aclasta 57 Mepact 57 Vimpat R 57 ELIQUIS 57 Angiox R 57 Adenuric ® 57 SANVAR 57 Photocure 57 Abstral 57 Frova ® 57 Hexvix 57 Soliris TM eculizumab 57 RoActemra 57 Pegintron 56 Keppra ® 56 YONDELIS 56 UPLYSO 56 indiplon capsules 56 Firdapse 56 brivaracetam 56 alvimopan 56 Biologics Licensing 56 Stavzor 56 SPARLON 56 Removab 56 OPAXIO 56 Vimpat ® lacosamide 56 Auxilium Pharma 56 Increlex 56 PhosLo 56 Onsolis 56 FRDA 56 Arranon 56 Santhera 56 Zavesca r 56 TYKERB 56 BENLYSTA 56 Cimzia ® certolizumab pegol 56 Tracleer R 56 Peginterferon alfa 2b 56 ONGLYZA ™ 56 Junovan 56 liver resection surgeries 56 Forsteo 56 IRESSA 56 Multaq R 56 Pirfenidone 56 Orphan Medicinal Products 56 Keppra ® levetiracetam 56 Avastin bevacizumab 56 FX Scorecard 56 Final Appraisal Determination 56 GTC recombinant form 56 Revolade 56 romiplostim 56 Increlex TM 56 Sanvar R 56 BRILINTA 56 Aclasta 56 STELARA TM 56 Promacta 56 Zebinix R 56 COMFORT II 56 velaglucerase alfa 56 XIAPEX 56 Vimpat 56 maribavir 55 EGRIFTA ™ 55 Fast Track designations 55 pediatric exclusivity 55 Orphan Drug Status 55 Vernakalant 55 Telzir 55 Kuvan 55 Receives Positive Opinion 55 #D#C# 55 SUMAVEL DosePro 55 Egrifta 55 Orencia abatacept 55 Serdolect ® 55 Eligard ® 55 Kynapid 55 Pixuvri 55 Somatuline Autogel 55 MEPACT 55 Toctino ® alitretinoin 55 Satraplatin 55 CELVAPAN H#N# 55 ZEGERID Capsules 55 Rasilamlo 55 Ventavis 55 Nivestim 55 Product Monograph 55 Cimzia R 55 Betaferon ® 55 MabCampath 55 NOXAFIL 55 ruxolitinib 55 CIP TRAMADOL ER 55 Sebivo 55 Alvesco R 55 Neupro ® 55 Scientific Advice 55 Clevudine 55 Biologic License Application BLA 55 Cladribine 55 CAELYX 55 ONTAK 55 Oracea ® 55 ARCOXIA 55 TAXUS Element Stent System 55 Bifeprunox 55 Ranexa R 55 Esbriet 55 Jevtana 55 oxymorphone ER 55 Nplate 55 Complete Response letter 55 vinflunine 55 Yondelis ® 55 Oncologic Drugs Advisory 55 Velcade bortezomib 55 Voraxaze ™ 55 TYGACIL 55 Esbriet ® 55 Ilaris 55 PLAVIX ® 55 Noxafil 55 Somatuline R Depot 55 Neupro 55 ORTHOVISC mini 55 desvenlafaxine 55 PrandiMet 55 Positive Opinion 55 XIAFLEX ™ 55 PMA submission 55 Sensipar 54 IV acetaminophen 54 Basilea Toctino R 54 CytoFab 54 Serdolect 54 gluteal injection 54 Japanese Encephalitis vaccine 54 ELAPRASE 54 TORISEL 54 Aflunov 54 Eucreas 54 Thyrogen 54 T Pred 54 Omnitrope 54 Diamyd ® 54 mifamurtide 54 sitaxsentan sodium 54 Complete Response 54 Ceplene ® 54 Vectibix panitumumab 54 sBLA 54 taliglucerase alfa 54 Febuxostat 54 FOSRENOL 54 severe hypercholesterolemia 54 Tracleer ® 54 ULTRASE 54 Nabi HB Intravenous 54 Marketing Authorisation Application MAA 54 Saphris 54 PillCam Colon 54 AVASTIN 54 Allovectin 7 ® 54 Decapeptyl ® 54 REPLAGAL 54 Mycamine 54 Cerepro 54 Targretin capsules 54 FDA Oncologic Drugs 54 Synvisc One 54 SUTENT ® 54 injectable formulations 54 methylnaltrexone 54 Application BLA 54 Orphan designation 54 MONOVISC 54 Clolar 54 rotigotine transdermal patch 54 CNTO 54 Evicel 54 LEUKINE 54 supplemental biologics 54 heterozygous FH 54 eprodisate Fibrillex TM 54 ATPace TM 54 ONSOLIS 54 Alvesco 54 Zingo TM 54 bazedoxifene 54 PRISTIQ 54 FDA Approvable Letter 54 NASDAQ Hearings Panel 54 Orazol 54 Keppra R 54 testosterone gel LibiGel 54 submit Biologics License 54 rilonacept 54 balsalazide tablet 54 Gleevec Glivec 54 Advagraf 54 Eloxatin ® 54 dalbavancin 54 Risperidone Oral Solution 54 FluLaval 54 ONGLYZA 54 Emezine 54 donepezil rivastigmine 54 Firdapse ™ amifampridine phosphate 54 Biologics License Application BLA 54 Preotact R 54 eltrombopag 54 Proquin XR 54 Exelbine NDA 54 CE Marking 54 Lupin Pharmaceuticals Inc. 54 Clinuvel 54 CLIA waiver 54 NUVIGIL 54 Exforge 54 silodosin 54 Tekturna HCT 54 Contura MLB 54 Actimmune R 54 Manja Bouman CEO 54 Orphan Drug Designation 54 Movectro 54 ACOMPLIA R 54 NEUPREX R 54 ORENCIA ® 54 Mylotarg 54 Zidovudine Tablets 54 Relistor 54 Velac 53 Biologics License Application 53 AMEVIVE 53 Brilique 53 FDA Advisory Panel 53 UVIDEM 53 Entereg 53 efalizumab 53 Glybera 53 Exforge HCT 53 HepaGam B TM 53 METOZOLV ODT 53 tocilizumab 53 Orphan Designation 53 Filgrastim 53 Boxed Warning 53 Swedish Orphan Biovitrum 53 Aloxi R 53 Dynepo 53 Dabigatran etexilate 53 Not Approvable 53 MERLIN TIMI 53 THALOMID 53 prGCD 53 Ranolazine 53 Zalbin 53 Renvela 53 albinterferon alfa 2b 53 Flutiform TM 53 Impax ANDA 53 Mircera 53 eprodisate KIACTA TM 53 Toctino 53 BRIM3 53 TRISENOX 53 PhotoCure 53 Cancidas 53 sNDA 53 CERVARIX R 53 BEMA Fentanyl 53 MERREM 53 Aridol 53 Actimmune ® 53 COLAZAL R 53 Afluria 53 Focalin XR 53 ATRIPLA 53 PDUFA Date 53 rThrombin 53 ambrisentan 53 Triage Stroke Panel 53 Hedgehog antagonist 53 Femara letrozole 53 PLAVIX R 53 Zirgan 53 PDUFA date 53 INVEGA ® 53 Tostrex 53 Jerini 53 RoACTEMRA 53 satraplatin 53 histamine dihydrochloride 53 Clolar ® 53 Accelerated Approval 53 Catena ® 53 CoStar stent 53 Onrigin 53 Aryplase 53 Arixtra 53 VISICOL R 53 Uplyso 53 metoprolol succinate 53 Combidex 53 unblind 53 Zavesca 53 ENTEREG 53 IXEMPRA 53 Orexo 53 CAPHOSOL 53 DYNEPO 53 Orphan Status 53 Yondelis 53 Cellegesic 53 Welchol 53 GetGoal Phase III 53 Abstral ® 53 ATryn R 53 cervical cancer vaccine Cervarix 53 Ranexa 53 Cimzia 53 Tasigna nilotinib 53 solifenacin succinate 53 Azilect ® 53 Ocrelizumab 53 XGEVA 53 Arzerra 53 Silenor NDA 53 Certolizumab pegol 53 #mg dose [002] 53 Fludara ® 53 SNT-MC#/idebenone 53 Glybera R 53 HepaGam B 53 R bivalirudin 53 sublingual tablets 53 Amrubicin 53 Biopartners 53 FAMPYRA 53 Lambert Eaton Myasthenic 53 Mirapexin 53 Viviant 52 Visian Toric ICL 52 vandetanib 52 Fast Track Status 52 DORIBAX 52 Somatuline Depot 52 REMICADE ® 52 Emselex 52 POSIDUR TM 52 Rectogesic 52 Betaferon 52 Veregen ® 52 Premarket Approval 52 Orphan Drug designation 52 naproxen esomeprazole magnesium 52 rasagiline tablets 52 Amrix 52 commercialize oritavancin 52 OLEPTRO 52 Amlodipine Besylate Tablets 52 oral FTY# 52 OMAPRO ™ 52 Gynazole 1 52 GTC recombinant human 52 Notified Body 52 OsmoPrep 52 TWYNSTA ® 52 Proprietary Medicinal Products CPMP 52 Humenza 52 PRIALT 52 Cladribine tablets 52 Tarceva TM 52 Aloxi Injection 52 Multaq 52 Receives Marketing Authorization 52 Lamictal ODT 52 GLASSIA 52 USFDA approval 52 Multiferon R 52 TYZEKA 52 AVADO 52 Alitretinoin 52 casopitant 52 pradefovir 52 Arzerra TM 52 SPRYCEL ® 52 Privigen 52 Seroquel XR 52 MAGE A3 ASCI 52 ARIXTRA 52 Kepivance 52 HuMax CD4 52 Gamunex 52 Keppra XR 52 Treximet 52 motavizumab 52 application sNDA 52 Octreolin 52 Biological License Application 52 FazaClo 52 CLIRS trial 52 budesonide MMX Phase III 52 Solasia 52 FlutiformTM 52 Bronchitol 52 Protopic 52 EVICEL 52 peginesatide 52 Fortigel 52 ARIXTRA R 52 Therabel 52 Centralised Procedure 52 Clinical Trial Application 52 Monovisc 52 ISO Vorin TM 52 acyclovir Lauriad R 52 EGRIFTA TM 52 pralatrexate 52 FDA Complete Response 52 EDQM 52 Silodosin 52 Uvidem 52 Symbyax 52 RELISTOR 52 AFSSAPS 52 Vpriv 52 COPAXONE ® 52 novel oral anticoagulant 52 Act PDUFA date 52 Entocort 52 Endeavor stent 52 Tygacil 52 Zytiga 52 Vimpat ® 52 daptomycin 52 synthetic lipoglycopeptide antibiotic 52 FACTIVE R gemifloxacin 52 darbepoetin alfa Aranesp 52 pirfenidone 52 TroVax 52 HepaSphere Microspheres 52 dirucotide 52 Xenazine ® 52 Firazyr ® 52 ANDA filer 52 intravenous acetaminophen 52 Premarket Approval Application 52 capsule formulation 52 chronic angina 52 REYATAZ R 52 cSSTI 52 Arixtra ® 52 MYLOTARG 52 Prexige 52 pertussis Tdap vaccine 52 YERVOY 52 Axentis Pharma 52 Ceflatonin 52 Striant 52 IND submission 52 Somatuline ® Autogel ® 52 generic Adderall XR 52 R brand eszopiclone 52 Mozobil 52 CUBICIN 52 Sanctura XR 52 Taxotere ® 52 prucalopride 52 Xolegel 52 RAPTIVA 52 Ambrisentan 52 MethyPatch 52 SCENESSE ® 52 XAGRID 52 interferon gamma 1b 52 Golimumab 52 Vitaros 52 Tibotec Pharmaceuticals Ltd. 52 QNEXA ® 52 Simulect 52 Xyzal 52 Ruconest ™ 52 APF# NDA 52 Ozurdex 52 NeoVisc 52 Gamunex C 52 Cipralex ® 52 SILENOR 52 BioDelivery Sciences 52 Nexavar sorafenib 51 Reasoned Opinion 51 Helsinn 51 Oracea 51 telavancin NDA 51 Azactam 51 Exelon Patch 51 DYSPORT TM 51 ADVEXIN 51 asenapine 51 XIAFLEX TM 51 Fibrillex TM 51 SPIRIVA HandiHaler 51 Coreg CR 51 clofarabine 51 Orapred ODT 51 Pivotal Phase III 51 MoxDuo IR 51 LensAR Laser System 51 AMITIZA R 51 Decapeptyl R 51 Fusilev 51 BioAlliance 51 SPRIX ® 51 DASISION 51 Doribax 51 FACTIVE tablets 51 human antithrombin 51 ReFacto 51 Syndrome LEMS 51 pomalidomide 51 NASDAQ BDSI 51 Schweizerhall 51 ENTEREG ® 51 approvability 51 Orphan Drug designations 51 granted Ortec 51 National Coverage Determination 51 pancreatic enzyme replacement 51 lercanidipine 51 reduce serum phosphate 51 Testim 51 JANUVIA 51 CLARITY study 51 Metozolv ODT 51 Fentanyl TAIFUN R 51 Prescribing Information 51 HepaSphere 51 supplemental Biologics License Application 51 aflibercept 51 Viramidine 51 MEZAVANT 51 APTIMA HPV assay 51 Wyeth Progenics 51 Xarelto 51 BeneFIX 51 Xyzal ® 51 WHO prequalification 51 DYSPORT 51 HBV infections 51 trastuzumab DM1 T DM1 51 Adenuric 51 VIDAZA 51 Keppra XR TM 51 cUTI 51 www.soliris.net 51 miconazole MBT 51 BioAlliance Pharma 51 Amlodipine Besylate 51 nonclinical studies 51 adenosine injection 51 Xigris 51 Onbrez Breezhaler 51 Soriatane 51 OZURDEX ® 51 Evoltra R 51 azficel T 51 Shire BioChem Inc. 51 Renvela ® 51 GALNS 51 JOULFERON 51 Nexavar ® 51 bifeprunox 51 BRAF V# mutation 51 Betaferon R 51 roflumilast 51 Linjeta 51 Multaq dronedarone 51 Intermezzo ® NDA 51 highly purified pasteurized 51 Prepandrix 51 DepoDur TM 51 FOLOTYN 51 PegIntron 51 Campath ® 51 Fampyra 51 tramiprosate ALZHEMED TM 51 Bonefos 51 Calcium Acetate 51 anidulafungin 51 PCV# 51 NEUPOGEN 51 submitted Marketing Authorization 51 guanfacine extended release 51 Ixempra 51 Cetrotide R 51 EXALGO 51 Premarket Approval PMA 51 Oracea TM 51 Reloxin R 51 LIALDA 51 Arzerra ofatumumab 51 Soliris eculizumab 51 Kaletra tablet 51 REVLIMID lenalidomide 51 Uracyst 51 REVLIMID R 51 FROVA 51 hylan GF 51 Luveris 51 RANK Ligand inhibitor 51 Rasagiline 51 ATryn ® 51 azelastine 51 Stelara 51 Oravig 51 Gilenia 51 Cysview 51 DATES Comments 51 sorafenib tablets 51 k Premarket Notification 51 Galvus 51 Menaflex implant 51 Besivance 51 Eligard 51 HyQ 51 Aptivus 51 Fortovase 51 Eliquis 51 APTIVUS 51 VALSTAR 51 VIMOVO 51 eCTD format 51 Afinitor ® 51 DepoDur 51 NDA submission 51 Hycamtin 51 DASISION study 51 aztreonam lysine 51 Xerese 51 Circadin 51 Astepro 51 octreotide acetate 51 Hexvix ® 51 Treanda 51 CAMPATH R 51 Pliaglis 51 Viracept 51 Rebif ® 51 levocetirizine 51 PDUFA Prescription Drug 51 R sorafenib tablets 51 magnetic irrigated catheter 51 Expanded Indication 51 Ramelteon 51 Desmoteplase 51 MOZOBIL 51 Visicol 51 Imvamune 51 Tredaptive 51 Potiga 51 Diamyd r 51 Kepivance ® 51 HepeX B 51 Paragraph IV Notice 51 BioSTAR R 51 SFDA approval 51 octagam ® 51 Augment Injectable 51 Dr. Damaj 51 Tekamlo 51 MitraClip R 51 bovine thrombin 51 Veronate 50 PREOS R 50 PREVU x LT 50 ATryn ® GTC recombinant 50 Dysport ® 50 MHLW 50 Barr ANDA 50 liprotamase 50 QVAR ® 50 Neuromodulation System 50 COLAZAL 50 Drug Eluting Stent System 50 NADiA ProsVue 50 TYSABRI 50 ® pioglitazone HCl 50 Fanapt TM 50 AERIUS 50 Ceflatonin ® 50 Loramyc ™ 50 Belimumab 50 nalbuphine ER 50 Rapinyl 50 pazopanib 50 sNDA filing 50 Biologic License Application 50 Eurand 50 Sancuso 50 Darunavir 50 ABILIFY R 50 ATryn 50 abatacept 50 Fanapt iloperidone 50 ISENTRESS 50 Periostat 50 Domilens 50 hereditary deficiency 50 mesylate tablets 50 Rescula 50 FTY# 50 Aviptadil 50 orBec 50 QNEXA 50 Fast Track Designation 50 acyclovir Lauriad ® 50 Extina 50 atypical antipsychotic medication 50 Arxxant 50 Aclasta Reclast 50 NASDAQ Listing Qualification 50 Tasigna 50 markets HP Acthar 50 Decentralized Procedure DCP 50 ANDA approvals 50 transfusional iron overload 50 Fodosine 50 fidaxomicin Phase 50 nasal calcitonin product 50 Approvable Letter 50 YAZ ® 50 Synerx 50 Amyvid 50 fluvoxamine maleate 50 Priority Review 50 Rhucin ® recombinant 50 biosimilar versions 50 Veramyst 50 mcg dose 50 Cloderm ® Cream 50 Proprietary Medicinal Products 50 investigational antiplatelet agent 50 Onco TCS 50 SUPPRELIN LA 50 Vandetanib 50 generic Allegra 50 PerClot 50 SUCCEED trial 50 Sonolith i move 50 CDP# 50 CYP#A# inhibitor 50 Zeneus 50 Medicines Agency 50 Votrient 50 myelodysplastic myeloproliferative diseases 50 Retisert TM 50 Mycograb 50 Onyx Pharma 50 Pentacel vaccine 50 Zevtera 50 fidaxomicin 50 Nycomed GmbH 50 Nasdaq ONXX today 50 Elevess 50 Sutent sunitinib 50 YONDELIS R 50 Dr. Gulfo 50 AVONEX 50 Cefprozil 50 LidoPAIN SP 50 Avelox 50 Asenapine 50 MyVax 50 Ruconest TM 50 Mimpara R 50 Herceptin trastuzumab 50 Frova R 50 RIGScan CR 50 Azzalure R 50 NOMAC E2 50 ZEGERID Chewable Tablets 50 Dated announcements 50 FASLODEX 50 Release Capsules 50 Fluarix vaccine 50 somatropin 50 Alair System 50 StaphVAX 50 Alvesco ® 50 Adentri 50 Intuniv 50 Actemra 50 XIAPEX ® 50 BiDil XR 50 XYZAL ® 50 NerPharMa 50 Fast Track designation 50 gadobutrol 50 UCB Cimzia 50 Vectical TM Ointment 50 pimecrolimus 50 Vibativ 50 Promus Element stent 50 Kit CD# positive 50 Invega 50 Drug Submission 50 Impavido R 50 Pulminiq 50 Pennsaid R 50 Sanofi Acomplia 50 XIBROM 50 Tracleer ® bosentan 50 Revlimid lenalidomide 50 Glucomed 50 Periostat R 50 Elidel 50 SIR Spheres 50 Rebetol 50 Wellbutrin XL R 50 sapropterin dihydrochloride 50 TOPROL XL 50 PIX# [002] 50 Cinryze ™ 50 pemetrexed Alimta 50 FDA Accelerated Approval 50 Veregen TM 50 UCB Keppra 50 Valtropin 50 NP2 Enkephalin 50 Afinitor everolimus 50 LEVADEX ™ 50 ELND# 50 ATRIPLA TM 50 Reverset 50 Aptivus ® 50 Tindamax 50 GEM #S 50 Lymphoseek 50 KAPVAY ™ 50 Plenaxis TM 50 HCl capsules 50 AMRIX 50 generic Lovenox 50 CLIA Waiver 50 Zolpidem Tartrate Tablets 50 NeoRecormon 50 KINRIX 50 ENDEAVOR III 50 Renagel ® 50 Fortical R 50 DNAwithPap TM Test 50 herpetic keratitis 50 RX ACCULINK 50 trabectedin 50 Troxatyl TM 50 PROVENGE ® 50 PrevOnco ™ 50 dopamine partial agonist 50 Nabi HB 50 ATPace 50 SpePharm 50 HFA MDI 50 Optaflu 50 SEASONIQUE 50 OMNARIS Nasal Spray 50 CIMZIA r 50 faropenem 50 Tavocept 50 OvaDx 50 Alferon N Injection 50 ceftobiprole 50 branded Rectogesic 50 OMNARIS