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(Click for frequent words.) 81 supplemental Biologics License Application 75 sNDA 74 Biologics License Application 73 supplemental biologics 72 application sNDA 72 Biologics License Application BLA 70 Marketing Authorization Application 69 Biologic License Application BLA 69 Marketing Authorisation Application 68 Marketing Authorization Application MAA 68 Application BLA 67 Orathecin 66 Supplemental Biologics License Application 66 Complete Response 65 BLA submission 65 Biologic License Application 65 Junovan 65 Civacir 64 MAA submission 64 Clolar 64 Biological License Application 63 UPLYSO 63 FDA Approvable Letter 63 FDA approvable letter 63 oral ridaforolimus 63 Intermezzo ® NDA 63 CIP TRAMADOL ER 63 New Drug Application 63 Ixempra 63 sNDA filing 63 BLA filing 63 ZEVALIN 63 ORENCIA ® 63 Marketing Authorisation Application MAA 62 lorcaserin NDA 62 PNP inhibitor 62 Ceflatonin 62 ixabepilone 62 PIX# trial 62 Dacogen injection 62 PMA submission 62 AVASTIN 62 IND Investigational New 62 BENLYSTA 62 Zenvia ™ 62 TREANDA 62 ADVEXIN 62 MyVax R 62 Premarket Approval PMA 62 PREOS 62 prGCD 62 ONGLYZA ™ 62 refractory chronic lymphocytic 61 IV acetaminophen 61 Acetavance 61 Zingo TM 61 JOULFERON 61 mifamurtide 61 registrational trial 61 VALSTAR 61 Nebido 61 Evoltra 61 Torisel 61 ONTAK 61 ruxolitinib 61 TYGACIL 61 OPAXIO 61 NDA submission 61 novel histone deacetylase 61 sNDAs 61 Cimzia TM 61 vinflunine 61 Jevtana 61 highly purified pasteurized 60 Biologics Licensing 60 liver resection surgeries 60 SILENOR TM 60 Marqibo 60 Application MAA 60 Onco TCS 60 dalbavancin 60 Evoltra ® 60 HepaGam B 60 Saforis 60 Drug Submission 60 taliglucerase alfa 60 Hycamtin 60 generation purine nucleoside 60 Premarket Approval Application 60 Feraheme ® 60 ponatinib 60 Ceplene 60 Prestara TM 60 forodesine 60 Marketing Authorization Applications 60 FIRAZYR 60 pralatrexate 60 Evoltra R 60 PREOS R 60 Arzerra TM 60 Onrigin 60 registrational 60 infusional 5-FU/LV 60 Fast Track Designation 60 Dalbavancin 60 L MTP PE 60 methylnaltrexone 60 NEBIDO R 60 T Pred 60 sNDA submission 60 phase IIb clinical 60 eltrombopag 60 MAGE A3 ASCI 60 balsalazide tablet 60 intravenous acetaminophen 60 Pirfenidone 60 Icatibant 60 Pivotal Phase III 60 Omigard 60 StaphVAX R 59 TRISENOX 59 Complete Response letter 59 Files Investigational 59 Actemra tocilizumab 59 Approvable Letter 59 TORISEL 59 APF# NDA 59 Amrubicin 59 granted Ortec 59 severe hypercholesterolemia 59 bazedoxifene 59 Cellegesic 59 PROVENGE ® 59 FDA Complete Response 59 Panzem R 59 Orphan Drug status 59 Personalized Immunotherapy 59 Tygacil 59 indiplon capsules 59 GATTEX TM 59 License Application sBLA 59 alvimopan 59 IL# PE#QQR 59 ferumoxytol Injection 59 Azedra 59 Tarceva TM 59 ZEVALIN ® 59 BEXXAR 59 clofarabine 59 Alvesco R 59 Voraxaze 59 NDA Submission 59 tafamidis 59 rasagiline tablets 59 Levoleucovorin 59 IMA# 59 Nexavar ® 59 interferon gamma 1b 59 ORENCIA R 59 Taxotere ® 59 PDUFA date 59 ALGRX 59 Romiplostim 59 Fast Track designations 59 Investigational Device Exemption 59 Aloxi Injection 59 metoprolol succinate 59 hoFH 59 Entereg 59 PLK1 SNALP 59 PANVAC VF 59 PrevOnco 59 Fodosine 59 INCB# [001] 59 ZEGERID Capsules 59 cutaneous T cell 59 Somatuline R Depot 59 FDA Accepts 59 TBC# 59 Stavzor 59 OMP designation 59 methylnaltrexone bromide 59 Zenpep 59 TYKERB 59 OFIRMEV 59 SinuNase 59 elotuzumab 59 PROMACTA 59 tolevamer 59 oxymorphone ER 59 Orphan Drug designations 59 BRIM2 59 RANK Ligand inhibitor 59 Anidulafungin 59 lintuzumab 59 Vandetanib 58 acyclovir Lauriad R 58 ATPace TM 58 BENLYSTA ® 58 Orphan Drug designation 58 oral prodrug 58 Vilazodone 58 virus HCV protease inhibitor 58 autologous cellular immunotherapy 58 Dyloject TM 58 Leukine 58 REPLAGAL 58 Approvable letter 58 vandetanib 58 cutaneous T 58 orphan designation 58 Clevudine 58 trastuzumab DM1 T DM1 58 Tekturna HCT 58 miconazole MBT 58 Act PDUFA date 58 lymphoma CTCL 58 TEMODAL 58 sublingual tablets 58 ZEGERID Chewable Tablets 58 Rhucin R 58 ANTEGREN 58 Promacta 58 Amitiza 58 YERVOY 58 investigational humanized monoclonal antibody 58 Arzerra ofatumumab 58 sevelamer carbonate 58 bicifadine 58 subcutaneous formulation 58 docetaxel Taxotere R 58 ketolide antibiotic 58 Preotact 58 HuMax CD4 58 dextromethorphan quinidine 58 ULTRASE 58 VISICOL R 58 romiplostim 58 alogliptin 58 octreotide acetate 58 VIVITROL ® 58 Aflunov 58 MOZOBIL 58 Nabi HB Intravenous 58 Treanda 58 TAXUS Element Stent System 58 SPRYCEL ® 58 LEUKINE 58 panitumumab 58 MabCampath 58 Biologics License Applications 58 posaconazole 58 BYETTA ® 58 ZOLINZA 58 Clolar ® 58 Soliris eculizumab 58 Troxatyl 58 HepeX B TM 58 Frova ® 58 Phase #/#a trial 58 Soliris TM eculizumab 58 RSR# 58 Eloxatin ® 58 Onrigin TM 58 JAK inhibitor 58 Keppra ® XR 58 thymalfasin 58 Loramyc R 58 Marketing Authorisation 58 HepaGam B TM 58 desvenlafaxine 58 pseudobulbar affect PBA 58 sunitinib malate 58 peginesatide 58 Avastin bevacizumab 58 Rhucin ® 58 Cimzia ® 58 RELISTOR ® 58 Entereg alvimopan 58 corticotropin injection 58 Viviant 58 Fibrillex TM 58 Silenor NDA 58 Numax 58 Accelerated Approval 58 Octreolin 58 Pixuvri 58 ABILIFY R 58 XYOTAX TM 58 FOLOTYN 58 Exalgo 58 MERLIN TIMI 58 k Premarket Notification 58 fidaxomicin 58 Lumizyme 58 Market Approval PMA 58 Zalbin 58 Elagolix 58 ofatumumab HuMax CD# 58 fluvoxamine maleate 58 Actemra 58 ISENTRESS 58 BLP# Liposome Vaccine 58 FOLOTYN ® 57 DORIBAX 57 faropenem 57 ZALBIN 57 Tezampanel 57 QNEXA 57 PDE4 inhibitor 57 Sanctura XR 57 mesylate tablets 57 RoACTEMRA 57 motavizumab 57 markets HP Acthar 57 TELCYTA 57 Phenoptin 57 L BLP# 57 Insegia 57 experimental immunotherapeutics antivirals AmpligeGI mucosa resulting 57 BRIM3 57 Augment Bone Graft 57 Uvidem 57 Genasense 57 PRN FDA Approves 57 Taxotere R 57 Augment Injectable 57 European Medicines Evaluation 57 Mepact 57 ERBITUX 57 Zytiga 57 ALVESCO R 57 Glufosfamide 57 Emezine 57 BYDUREON 57 HCV protease inhibitor 57 efalizumab 57 Exelbine 57 PrevOnco ™ 57 teduglutide 57 Q#IR 57 Bezielle 57 Firazyr 57 Contrave NDA 57 Phase IIb trials 57 formerly LymphoStat B 57 Aloxi ® 57 Entereg R 57 vapreotide acetate 57 SILENOR 57 refractory Hodgkin lymphoma 57 Glatiramer Acetate 57 Pruvel 57 LibiGel ® 57 proprietary transdermal patch 57 Vfend 57 axitinib 57 PROVENGE sipuleucel T 57 ibuprofen Injection 57 huC# DM4 57 ARCOXIA 57 FUSILEV 57 romidepsin 57 Cimzia ® certolizumab pegol 57 cell lymphoma CTCL 57 Cimzia certolizumab pegol 57 MNTX 57 AMRIX 57 casopitant 57 vinorelbine emulsion 57 Kynapid 57 IND submission 57 Romidepsin 57 PDX pralatrexate 57 Ferumoxytol 57 Cladribine 57 FROVA 57 Fusilev 57 OncoVEX GM CSF 57 MONOVISC 57 rhThrombin 57 GRAS notification 57 HP Acthar Gel repository 57 TRISENOX ® 57 PTK ZK 57 Somatuline R Autogel R 57 Viramidine 57 T DM1 57 GTC recombinant form 57 TYZEKA 57 Fast Track designation 57 Reclast Aclasta 57 Velac 57 Ranexa R 57 Phase IIB 57 FACTIVE R gemifloxacin 57 Pegloticase 57 oral methylnaltrexone 57 ISENTRESS raltegravir 57 Joulferon 57 SYCREST 57 miconazole Lauriad R 57 Focalin XR ® 57 sorafenib tablets 57 temsirolimus 57 Privigen 57 Aclasta 57 Exelbine NDA 57 FTY# 57 Announces Tentative Approval 57 NUVIGIL 57 Targretin 57 Omigard TM 57 ImClone Erbitux 57 single injection viscosupplement 57 TELINTRA 57 Xanafide 57 SPD# 57 Ventavis 57 IRX 2 57 CDP# 57 Eltrombopag 57 ABILIFY ® 57 Marketing Authorization 57 Orphan Drug Status 57 INDs 57 AZILECT ® 57 Camptosar ® 57 Xyrem ® 57 DASISION 57 paliperidone ER 57 Fast Track Status 57 Bonefos 57 Lenocta 57 MK #B 57 Clinical Trial Application 57 Stimuvax R 57 pantoprazole sodium 56 AzaSite Plus 56 Satraplatin 56 Vidaza 56 Xinlay 56 Renvela ® 56 JZP 6 56 dacetuzumab 56 CERVARIX R 56 NEBIDO 56 Advexin 56 nanofiltered plasma derived 56 REVLIMID lenalidomide 56 radiation sensitizer 56 histamine dihydrochloride 56 Traficet EN 56 Lenalidomide 56 Completes Patient Enrollment 56 TRANSDUR Bupivacaine 56 investigational monoclonal antibody 56 PXD# 56 Ceflatonin ® 56 Restanza 56 lucinactant 56 Extina 56 MOVIPREP R 56 OvaRex ® MAb 56 Xelox 56 Aurexis 56 Peginterferon alfa 2b 56 RIGScan CR 56 FIRMAGON R 56 Pazopanib 56 REBETOL combination therapy 56 Phase III Clinical Trial 56 Corlux 56 OMNARIS HFA 56 ZEGERID Powder 56 Lenocta TM 56 Nexavar sorafenib 56 Fortigel 56 ANDAs 56 ENTEREG ® 56 torezolid phosphate 56 FavId 56 Mylan Receives Approval 56 Somatuline Depot 56 Zorbtive TM 56 valopicitabine 56 sapacitabine 56 LEP ETU 56 Fortical R 56 ROTATEQ 56 Alferon N Injection 56 CIMZIA TM 56 THALOMID 56 LEVADEX ™ 56 Dabigatran etexilate 56 Premarket Approval 56 Afluria 56 eprodisate KIACTA TM 56 bosutinib 56 albinterferon alfa 2b 56 Prodarsan R 56 SPARLON 56 trabectedin 56 Plicera 56 Phase Ib study 56 sapropterin dihydrochloride 56 Pixantrone 56 Glybera R 56 Vion Pharmaceuticals 56 Zelrix 56 custirsen 56 Acetavance TM 56 Ampligen r 56 INC# 56 PDUFA Date 56 SEROQUEL XR 56 NOXAFIL 56 Priority Review 56 DAYTRANA TM 56 Drug Application 56 Loramyc 56 CIP ISOTRETINOIN 56 Phase IIa trial 56 Submits Supplemental 56 OvaRex R 56 reslizumab 56 injectable formulation 56 ANDA containing 56 confirmatory Phase III 56 SEBIVO 56 vemurafenib 56 Orphan Drug Designation 56 Expanded Indication 56 pivotal Phase III 56 Orencia 56 SEASONALE R 56 SinuNase TM 56 octreotide implant 56 Asentar 56 phase IIb trial 56 sumatriptan injection 56 Folotyn 56 Urocidin 56 LAF# 56 IND Application 56 Pralatrexate 56 talactoferrin 56 Pivotal Phase 56 YONDELIS 56 Raptiva R 56 Relistor 56 placebo controlled Phase 56 sargramostim 56 Xcytrin R 56 vorinostat 56 AEG# 56 Campath ® 56 BLOOM DM 56 Vidaza azacitidine 56 pixantrone NDA 56 Dyloject 56 Soriatane R 56 IIa trial 56 motexafin gadolinium Injection 56 LymphoStat B belimumab 56 human lactoferrin 56 ACTEMRA 56 Solzira 56 Cimzia R 56 Proellex TM 56 CONBRIZA 56 submitted supplemental Biologics 56 postoperative ileus POI 56 EOquin 56 Trelstar R 56 MyVax 56 USFDA approval 56 anidulafungin 56 Velcade bortezomib 56 ganetespib 56 BRILINTA 56 Tasigna nilotinib 56 Ceplene TM 56 cycle oral contraceptive 56 candidate REP# 56 ridaforolimus 56 KNS # 56 Targretin capsules 56 low dose cytarabine 56 Febuxostat 56 ThermoDox ® 56 Allovectin 7 56 BEMA TM Fentanyl 56 LE SN# 56 opioid induced bowel dysfunction 56 Sanvar R 56 enzastaurin 56 investigational antiplatelet agent 56 Dasatinib 56 Raptiva ® 56 Doribax 56 Vernakalant 56 non metastatic osteosarcoma 56 approvable letters 56 Crofelemer budesonide foam 56 amrubicin 56 telavancin NDA 56 Synvisc One 56 Azilect ® 56 Certican 56 Inhalation Aerosol 56 DPX Survivac 56 Pentacel vaccine 56 SEASONIQUE 56 Zolinza 56 RECOTHROM R 56 OMAPRO ™ 56 LEVADEX TM 56 5mg #mg #mg 56 GATTEX 56 initiated Phase Ib 56 RG# [001] 56 AMITIZA R 56 cinacalcet HCl 56 CRMD# 56 NerPharMa 56 MT# MEDI 56 HDAC Inhibitor 55 JANUVIA 55 AP# [003] 55 indolent NHL 55 NGX# 55 PLAVIX ® 55 Besivance 55 FDA Oncologic Drugs 55 Increlex TM 55 Silenor ® doxepin 55 Phase IIb Trial 55 Junovan TM 55 generic Copaxone 55 mTOR inhibitor 55 ANDA filings 55 Cinryze TM 55 submitted Biologics License 55 Temsirolimus 55 Ketotransdel 55 phase IIb 55 Proxinium TM 55 PRISTIQ 55 Zenvia Phase III 55 EFAPROXYN 55 Oncaspar 55 ILUVIEN ® 55 PRECISE trial 55 Phase III clinical 55 silodosin 55 BEMA Fentanyl 55 palifosfamide 55 Telatinib 55 PMA Supplement 55 apaziquone 55 Zarnestra 55 Erbitux cetuximab 55 Sandostatin LAR 55 investigational hepatitis B 55 FORTIS M trial 55 Ixabepilone 55 FDA APPROVES 55 Atrasentan 55 Oracea TM 55 herpetic keratitis 55 Taxotere docetaxel 55 sorafenib Nexavar 55 lasofoxifene 55 Oracea R 55 Panzem R NCD 55 Inhalation Solution 55 AAG geldanamycin analog 55 atacicept 55 Soriatane 55 Cloretazine 55 ezogabine 55 Bazedoxifene 55 LHRH antagonist 55 Gemzar ® 55 diarrhea predominant irritable 55 Strativa 55 GLASSIA 55 novel oral anticoagulant 55 LibiGel NDA 55 phase Ib 55 satraplatin 55 Cladribine Tablets 55 ADVEXIN p# therapy 55 ARIKACE 55 Eligard R 55 dasatinib 55 Ozarelix 55 Investigational 55 FluLaval 55 ELACYT 55 tamibarotene 55 Amigal 55 PEGylated anti 55 Pivotal Study 55 Increlex R 55 Loramyc ® 55 Dapagliflozin 55 Vidaza R 55 GTC recombinant human 55 Tasimelteon 55 VPRIV 55 pediatric exclusivity 55 Horizant 55 pegloticase 55 Nuvion 55 ATryn R 55 OMNARIS Nasal Spray 55 Zevalin 55 Meets Primary Endpoint 55 Humira adalimumab 55 ISTODAX 55 Pegintron 55 SUPPRELIN R LA 55 zalutumumab 55 Keppra XR 55 NVA# 55 Virulizin R 55 Vicriviroc 55 Vectibix panitumumab 55 CLARITY study 55 Sprycel dasatinib 55 Ticagrelor 55 JZP 55 Pivotal Trial 55 AVADO 55 Replagal 55 NV1FGF 55 XIBROM 55 Camvia 55 leading oral taxane 55 LymphoStat B 55 EOquin TM 55 commercialize oritavancin 55 ACAPODENE 55 LidoPAIN SP 55 ZADAXIN ® 55 Naglazyme 55 Edurant 55 Preos 55 Oral BDP 55 Pennsaid R 55 R bendamustine hydrochloride 55 Cloretazine ® 55 amifampridine phosphate 55 liprotamase 55 Nycomed GmbH 55 Phase III Pivotal 55 GARDASIL ® 55 StaphVAX 55 Trobalt 55 deforolimus 55 belinostat 55 Gynazole 1 55 Zelapar 55 Vimpat ® lacosamide 55 Arixtra 55 docetaxel Taxotere ® 55 Oporia 55 abiraterone acetate 55 alvespimycin 55 Bortezomib 55 Arikace 55 Renvela 55 Rescula 55 SEROQUEL R 55 Docetaxel 55 Zensana 55 arsenic trioxide injection 55 FDA Orphan Drug 55 commercialize toremifene 55 indacaterol 55 TOCOSOL Paclitaxel 55 ongoing Phase 1b 55 Orphan Status 55 phase III isavuconazole 55 Aclasta Reclast 55 Factor VIIa 55 vernakalant oral 55 KRN# 55 HEPLISAV TM 55 BioGlue R 55 KALBITOR ® 55 Brentuximab Vedotin SGN 55 XYOTAX 55 ONSOLIS 55 Ophena TM 55 Rebif ® 55 Rhucin 55 Revlimid lenalidomide 55 zileuton CR 55 Denufosol 55 Menveo 55 pexelizumab 55 TroVax ® 55 Afinitor everolimus 55 orally administered inhibitor 55 Phase 2b clinical 55 BioGlue ® 55 Luveniq 55 LymphoStat B TM 55 liposomal formulation 55 ecallantide 55 telbivudine 55 Azixa 55 vilazodone 55 TransVax TM 55 HGS ETR2 55 OncoVEX 55 Enjuvia 55 metastatic hormone refractory 55 Fortovase 55 Phase 2a trial 55 Evicel 55 Japanese Encephalitis vaccine 55 orphan medicinal product 55 alefacept 55 investigational immunotherapy 55 Tamibarotene 55 HspE7 55 IgG1 monoclonal antibody 55 Phase 1b trial 55 ADVANCE PD 55 oritavancin 55 Fludara 55 ambrisentan 55 Zavesca r 55 iloperidone 55 quetiapine fumarate 55 Mycograb 55 SUMAVEL 55 Keppra ® levetiracetam 55 ACUROX 55 Synvisc ONE 55 Ceplene histamine dihydrochloride 55 Fidaxomicin 55 Campath 55 Tekturna Rasilez 55 postherpetic neuralgia PHN 55 Xifaxan 55 Krystexxa 55 PF # [002] 55 Increlex ® 55 COMFORT II 55 depressive episodes associated 55 histone deacetylase HDAC inhibitor 55 Fx #A 55 Clofarabine 55 rThrombin 55 Delayed Release 55 Filgrastim 55 Carfilzomib 55 systemic immunosuppressive drugs 55 randomized Phase III 55 PROSTASCINT R 55 sipuleucel T 55 decitabine 55 Staphylococcus aureus Polysaccharide Conjugate 55 Octreotide 55 Phase lll 55 celgosivir 55 Friedreich Ataxia FRDA 55 Oral Calcitonin 55 PEGINTRON TM 55 enoxaparin sodium injection 55 phase 2a 55 EXALGO 55 Mylotarg 55 EMBEDA 54 investigational oral hepatitis C 54 Pivotal Clinical Trial 54 receptor tyrosine kinase inhibitor 54 PROMUS Element Stent System 54 FUSILEV ® 54 Evoltra TM 54 KRYSTEXXA TM pegloticase 54 Phase 2b study 54 SNT MC# 54 pexiganan 54 Boceprevir 54 CIMZIA TM certolizumab pegol 54 Zerenex 54 Anthim 54 Gleevec Glivec 54 GV# [001] 54 KINRIX 54 Ambrisentan 54 PEG SN# 54 PROVIGIL 54 Focetria 54 Anturol ® 54 mitogen activated ERK kinase 54 Yondelis ® 54 Patient Enrollment 54 Dual Opioid 54 dasatinib Sprycel ® 54 Zidovudine Tablets 54 Ranolazine 54 novel trazodone formulation 54 dose escalation Phase 54 Kuvan R 54 ocular formulation 54 ANDA submission 54 Theratope 54 RhuDex ® 54 PhosLo 54 Prestara 54 SUCCEED trial 54 Rituxan rituximab 54 ADP receptor antagonist 54 Afinitor ® 54 AeroLEF TM 54 azacitidine 54 refractory APL 54 testosterone gel LibiGel 54 Sutent sunitinib 54 XL# anticancer compounds 54 ELADUR 54 CLIA waiver 54 Divalproex Sodium 54 Cutaneous T 54 orBec 54 SUTENT ® 54 Aloxi R 54 Ampligen R 54 SPRIX ® 54 cetuximab Erbitux R 54 Silenor ® 54 Noxafil 54 Ofirmev 54 Linjeta TM 54 Actonel ® 54 pirfenidone 54 paliperidone palmitate 54 CHMP opinion 54 Androxal TM 54 OrCel R 54 registrational studies 54 Polymer Microspheres 54 Xenazine ® 54 icatibant 54 Vascular Wrap TM 54 topical NSAID 54 include Alferon N 54 maribavir 54 nonclinical studies 54 human C1 inhibitor 54 Vicinium TM 54 SPL# Gel vaginal microbicide 54 Esbriet ® 54 Surgical Adhesive 54 rNAPc2 54 multicenter Phase II 54 ELIQUIS 54 R#/MEM # 54 Kit CD# positive 54 Entocort 54 OLEPTRO 54 Rebetol 54 capsules USP 54 SANVAR 54 anticancer compound 54 Sanofi Aventis Taxotere 54 Golimumab 54 Ocrelizumab 54 docetaxel Taxotere 54 chronic idiopathic thrombocytopenic purpura 54 rolling Biologics License 54 pan histone deacetylase 54 ITAX 54 Mozobil 54 Rotarix R 54 ENLIGHT 54 Zactima 54 DOR# 54 Irinotecan 54 Seroquel XR 54 Nasdaq OSCI 54 refractory cutaneous T 54 Anturol TM 54 Pemetrexed 54 DIFICID ™ 54 investigational 54 etanercept Enbrel 54 RAD# [003] 54 huN# DM1 54 product BioThrax ® 54 Sprycel 54 Phase IIb clinical trials