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(Click for frequent words.) 75 application sNDA 75 sBLA 70 supplemental Biologics License Application 70 Biologics License Application BLA 69 New Drug Application 68 Marketing Authorization Application MAA 68 Marketing Authorisation Application 67 Biologics License Application 67 Marketing Authorization Application 66 FDA approvable letter 65 Application BLA 65 Complete Response 65 Drug Submission 65 Marketing Authorisation Application MAA 64 NDA submission 63 FDA Approvable Letter 63 Biologic License Application BLA 63 alvimopan 63 Clolar 63 Biological License Application 63 MAA submission 62 Marqibo 62 BLA submission 62 desvenlafaxine 62 SEROQUEL XR 62 QNEXA 62 BLA filing 62 sNDA filing 62 severe hypercholesterolemia 62 Pivotal Phase III 62 Orathecin 62 balsalazide tablet 62 sNDAs 61 Biologic License Application 61 Zenvia ™ 61 Junovan 61 corticotropin injection 61 supplemental biologics 61 Firazyr 61 FDA Complete Response 61 NUVIGIL 61 ezogabine 61 TYGACIL 61 Intermezzo ® NDA 61 registrational 61 Dacogen injection 61 Premarket Approval Application 61 T Pred 61 BYETTA ® 61 PREOS 61 Application MAA 61 Cimzia TM 61 ANTEGREN 61 Premarket Approval PMA 60 HP Acthar Gel repository 60 fluvoxamine maleate 60 FROVA 60 FIRAZYR 60 rasagiline tablets 60 Cimzia ® 60 Ventavis 60 eltrombopag 60 Acetavance 60 paliperidone palmitate 60 sNDA submission 60 Jevtana 60 Cladribine Tablets 60 Fast Track designation 60 pseudobulbar affect PBA 60 mometasone furoate 60 ONGLYZA ™ 60 diabetic neuropathic pain 60 PRISTIQ 60 Evoltra R 60 FOLOTYN ® 60 Divalproex Sodium 60 Icatibant 60 approvable letter 60 Nebido 60 clofarabine 60 Cellegesic 59 oxymorphone ER 59 VIVITROL ® 59 Actemra tocilizumab 59 CIP TRAMADOL ER 59 Abilify aripiprazole 59 PDUFA date 59 Troxatyl 59 THALOMID 59 Extended Release Capsules 59 Pirfenidone 59 SILENOR TM 59 Biologics Licensing 59 Drug Application 59 ALVESCO R 59 Tasigna nilotinib 59 Stavzor 59 ORENCIA ® 59 FDA Accepts 59 cutaneous T cell 59 lorcaserin NDA 59 forodesine 59 dextromethorphan quinidine 59 investigational compound 59 AstraZeneca Symbicort 59 PMA submission 59 Rhucin R 59 mifamurtide 59 OFIRMEV 59 Torisel 59 Focalin XR 59 desvenlafaxine succinate 59 oral ridaforolimus 59 Promacta 59 Act PDUFA date 59 confirmatory Phase III 59 Relistor 59 cell lymphoma CTCL 59 Dyloject TM 59 RoACTEMRA 59 sapropterin dihydrochloride 59 Orphan Drug status 59 octreotide implant 59 VALSTAR 59 DORIBAX 59 generation purine nucleoside 59 Sanctura XR 59 acyclovir Lauriad R 59 NEBIDO 59 glatiramer acetate 59 non constipation irritable 59 oral prodrug 59 PNP inhibitor 59 Ranolazine 59 Frova 59 refractory chronic lymphocytic 59 NVA# 59 atypical antipsychotic medication 59 indiplon capsules 59 aripiprazole Abilify 58 Onrigin 58 subcutaneous formulation 58 Ceflatonin 58 BYDUREON 58 lubiprostone 58 ZEGERID Chewable Tablets 58 liver resection surgeries 58 Zelrix 58 elotuzumab 58 Complete Response letter 58 orphan designation 58 PREOS R 58 SILENOR 58 indacaterol 58 NEBIDO R 58 Vilazodone 58 methylnaltrexone 58 PROMACTA 58 Dalbavancin 58 L MTP PE 58 SPRYCEL ® 58 markets HP Acthar 58 reslizumab 58 Frova ® 58 ZEGERID Capsules 58 OMNARIS HFA 58 European Medicines Evaluation 58 Roflumilast 58 ruxolitinib 58 infusional 5-FU/LV 58 Seroquel XR 58 miconazole Lauriad ® 58 Luveniq 58 commercialize oritavancin 58 bicifadine 58 DASISION 58 Files Investigational 58 formoterol fumarate 58 FUSILEV 58 dalbavancin 58 Alvesco R 58 alogliptin 58 proprietary transdermal patch 58 Zingo TM 58 prGCD 58 Ranexa R 58 prodrug stimulant 58 Oral Solution 58 Telavancin 58 depressive episodes associated 58 Phase IIb trials 58 ARCOXIA 58 RANK Ligand inhibitor 58 sublingual tablets 58 hoFH 58 cutaneous T 58 Cimzia ® certolizumab pegol 58 ABILIFY R 58 Phase Ib 58 Voraxaze 57 Approvable Letter 57 Focalin XR ® 57 novel histone deacetylase 57 Xyrem ® 57 License Application sBLA 57 Evoltra 57 sunitinib malate 57 SPARLON 57 HFA MDI 57 Levoleucovorin 57 Plicera 57 LIALDA 57 SYCREST 57 Inhalation Aerosol 57 ALGRX 57 Announces Tentative Approval 57 Phase III clinical 57 IND submission 57 methylnaltrexone bromide 57 PROVIGIL 57 TRANSFORMS 57 Renvela 57 Preotact 57 albinterferon alfa 2b 57 Glatiramer Acetate 57 fidaxomicin 57 Romiplostim 57 Oporia 57 Mylan Receives Approval 57 Ixempra 57 GATTEX TM 57 Omigard 57 Inhalation Solution 57 herpetic keratitis 57 pantoprazole sodium 57 ferumoxytol Injection 57 Orphan Drug designation 57 monotherapy 57 DEXILANT 57 Zorbtive TM 57 interferon gamma 1b 57 Amitiza 57 postoperative ileus POI 57 Tarceva TM 57 Cimzia certolizumab pegol 57 teduglutide 57 ACTEMRA 57 Roche Actemra 57 EOquin 57 peginesatide 57 Keppra R 57 FIRMAGON R 57 Silenor ® doxepin 57 PIX# trial 57 Strativa 57 Orphan Drug designations 57 Clofarabine 57 Treanda 57 DAYTRANA TM 57 Phase IIb Trial 57 hydrochloride tablets 57 ofatumumab 57 Zyflo 57 IND Investigational New 57 Betaferon R 57 Luvox CR 57 romiplostim 57 Orally Disintegrating Tablets 57 ACOMPLIA R 57 pivotal Phase III 57 Bronchitol 57 Keppra ® 57 Risperidone Oral Solution 57 Aclasta 57 approvable letters 57 Aryplase 57 REVLIMID lenalidomide 57 ENTEREG ® 57 relapsed refractory multiple myeloma 57 SAPHRIS 57 ONTAK 57 ABILIFY ® 57 Panzem R 57 Marketing Authorization Applications 57 vandetanib 57 Anturol TM 57 pioglitazone HCl 57 Amrubicin 57 Vimovo 57 APF# 57 NDA Submission 57 celgosivir 57 Rhucin 57 Gel repository corticotropin injection 57 Dexilant 57 Raptiva ® 57 Neurodex 57 ITAX 57 FDA Oncologic Drugs 57 FDA APPROVES 57 OMNARIS Nasal Spray 57 guanfacine extended release 57 Clinical Trial Application 57 SPD# 57 MERLIN TIMI 57 Glybera R 57 bazedoxifene 57 Soliris TM eculizumab 57 Sprycel dasatinib 57 Frova R 57 naproxen esomeprazole magnesium 57 Extended Release Tablets 57 Zenpep 57 brivaracetam 57 vinflunine 57 Zalbin 57 prucalopride 57 Zenvia 57 tezampanel 57 Keppra ® levetiracetam 57 Keppra ® XR 57 miconazole MBT 57 Neupro R 57 Lubiprostone 56 Zytiga 56 levetiracetam Keppra 56 VPRIV 56 VYVANSE 56 velaglucerase alfa 56 APF# NDA 56 Sular formulation 56 Supplemental Biologics License Application 56 BENLYSTA 56 Ambrisentan 56 Tygacil 56 ZOLINZA 56 post herpetic neuralgia PHN 56 lucinactant 56 Phase 2a trial 56 ABILIFY 56 Pixuvri 56 investigational atypical antipsychotic 56 Targretin capsules 56 Cinryze TM 56 Krystexxa 56 Market Approval PMA 56 TAXUS Element Stent System 56 Increlex R 56 phase IIb clinical 56 enzastaurin 56 Eltrombopag 56 oral methylnaltrexone 56 Traficet EN 56 Etanercept 56 silodosin 56 AZILECT R 56 Raptiva R 56 serotonin norepinephrine reuptake inhibitor 56 Entereg R 56 hydrochloride extended 56 ofatumumab HuMax CD# 56 IIa trial 56 docetaxel Taxotere R 56 metastatic hormone refractory 56 resubmission 56 SEROQUEL 56 Ranexa 56 FACTIVE tablets 56 Arixtra ® 56 mTOR inhibitor 56 Phase Ib study 56 DPP4 inhibitor 56 Evoltra ® 56 Eli Lilly Cymbalta 56 Vandetanib 56 Corlux 56 Kuvan R 56 Kuvan 56 opioid induced bowel dysfunction 56 TEMODAL 56 PDUFA Date 56 iloperidone 56 Tezampanel 56 efalizumab 56 Fast Track Designation 56 Levetiracetam 56 formerly LymphoStat B 56 Phase III Clinical Trial 56 Phase 2b clinical 56 MONOVISC 56 ALVESCO HFA 56 inhaled formulation 56 SUPPRELIN R LA 56 Soriatane 56 chronic idiopathic thrombocytopenic purpura 56 Pegloticase 56 Kynapid 56 Altabax 56 Octreolin 56 PROVENGE ® 56 Celgene Thalomid 56 Zyflo CR 56 Ustekinumab 56 tiapamil 56 ponatinib 56 LAF# 56 Entereg 56 Keppra XR 56 Phenoptin 56 Arzerra ofatumumab 56 mesylate tablets 56 AVASTIN 56 Phase 1b clinical 56 NOXAFIL 56 REMOXY R 56 MOVIPREP R 56 Somatuline Depot 56 Xenazine ® 56 BRILINTA 56 RSR# 56 Complete Response Letter 56 myelodysplastic myeloproliferative diseases 56 SNT MC# 56 BRIM2 56 PDE4 inhibitor 56 NDA resubmission 56 LibiGel ® 56 Mirapexin 56 intravenous acetaminophen 56 LEUKINE 56 Mepact 56 Vimpat R 56 Exforge 56 Fibrillex TM 56 CYCLOSET 56 Elagolix 56 Abatacept 56 CIMZIA TM 56 Vicriviroc 56 ketolide antibiotic 56 N acetylgalactosamine 6 56 ISENTRESS raltegravir 56 novel bactericidal 56 TYKERB 56 oral formulation 56 Accelerated Approval 56 Esbriet ® 56 Sycrest 56 Bupropion HCl ER 56 Clolar ® 56 ONSOLIS 56 Lixisenatide 56 GALNS 56 ACAPODENE 56 Requip XL 56 sevelamer carbonate 55 Oracea TM 55 Pivotal Phase 55 Zenvia Phase III 55 Edurant 55 SNRI 55 Loramyc 55 AZILECT ® 55 Vfend 55 adalimumab Humira 55 Marketing Authorisation 55 Investigational Device Exemption 55 Drug Submission NDS 55 ixabepilone 55 vapreotide acetate 55 Delayed Release 55 ILLUMINATE 55 Keppra XR TM 55 autologous cellular immunotherapy 55 Feraheme ® 55 Ceplene 55 Cimzia 55 Meets Primary Endpoint 55 FTY# 55 TELINTRA 55 MK #B 55 Somatuline R Autogel R 55 Taxotere ® 55 ISENTRESS 55 Asmanex 55 Xinlay 55 metoprolol succinate 55 Zolpimist 55 Nuedexta 55 TORISEL 55 Tekturna HCT 55 FACTIVE R gemifloxacin 55 rabeprazole 55 Trobalt 55 EMSAM 55 ISTODAX 55 Invega 55 ORENCIA R 55 Trelstar R 55 tocilizumab 55 Glumetza TM 55 SEASONALE R 55 Oracea 55 liprotamase 55 romidepsin 55 icatibant 55 posaconazole 55 Velac 55 balsalazide disodium 55 dopamine partial agonist 55 placebo controlled Phase 55 Aloxi Injection 55 Release Capsules 55 treat opioid induced 55 fostamatinib 55 INDs 55 diabetic gastroparesis 55 single injection viscosupplement 55 DPP4 55 VISICOL R 55 Trexima 55 octreotide acetate 55 REPLAGAL 55 ELADUR 55 CIMZIA TM certolizumab pegol 55 Phase IIa trial 55 Azedra 55 inhalation aerosol 55 telavancin NDA 55 azacitidine 55 diabetic peripheral neuropathic pain 55 quetiapine fumarate 55 BENLYSTA ® 55 vidofludimus 55 Natalizumab 55 JANUVIA 55 Peginterferon alfa 2b 55 Golimumab 55 GATTEX ™ 55 Celgene Revlimid 55 virus HCV protease inhibitor 55 Amrix 55 Civacir 55 Fludara 55 pralatrexate 55 DIFICID ™ 55 Galvus 55 Phase IIa 55 Arixtra 55 Orapred ODT 55 Saforis 55 tanespimycin 55 hypereosinophilic syndrome 55 Phase 2b study 55 ARIKACE 55 Fampridine SR 55 mg dose 55 Sanvar R 55 BEMA TM Fentanyl 55 OMP designation 55 Firdapse 55 diarrhea predominant irritable 55 pomalidomide 55 buccal tablets 55 Actemra 55 ULTRASE 55 SYMBICORT 55 COMFORT II 55 indolent NHL 55 Huntexil 55 human C1 inhibitor 55 Methylin 55 POSIDUR TM ELADUR TM 55 phase Ib 55 ADVANCE PD 55 Eszopiclone 55 aztreonam lysine 55 Gabapentin GR 55 lasofoxifene 55 Aloxi 55 HGS# 55 highly purified pasteurized 55 budesonide inhalation suspension 55 Phase IIb Clinical Trial 55 post menopausal osteoporosis 55 vinorelbine emulsion 55 Prestara 55 REMICADE ® 55 Xifaxan 55 DDP# 55 Lodotra 55 Viviant 55 Phase 2b trial 55 post operative ileus 55 lomitapide 55 lintuzumab 55 Neupro ® 55 lintuzumab SGN 55 rotigotine transdermal patch 55 REBETOL combination therapy 55 Extended Release 55 adenosine injection 55 Phase IIIb 55 Rebif ® 55 Lenalidomide 55 Revlimid lenalidomide 55 Onco TCS 55 peripherally acting 55 investigational oral 55 casopitant 55 Azilect ® 55 Ultracet R 55 Phase 2b 55 Phase IIIb clinical 55 Chronic Idiopathic Constipation 55 Evamist TM 55 subcutaneously administered 55 orphan medicinal product 55 Transdermal System 55 containing granisetron 55 INC# 55 NUEDEXTA ™ 55 BLOOM DM 55 albiglutide 55 JZP 6 55 vilazodone 55 memantine HCl 55 Entocort 55 Lamictal ODT 55 IRESSA 55 PXD# 55 painful diabetic neuropathy 55 BRIM3 55 EvaMist TM 55 inhaled antibiotic 55 GRALISE 55 registrational trial 55 severe gastroparesis 55 abiraterone acetate 55 pregabalin Lyrica 55 Onsolis 55 Bifeprunox 55 IV acetaminophen 55 Dapagliflozin 55 Orphan Drug Status 55 motavizumab 55 ethinyl estradiol tablets 55 bosutinib 55 CoFactor 55 Romidepsin 55 Anidulafungin 55 Efficacy Results 55 Phase III Trial 55 Combunox 55 ADDERALL XR 55 Increlex ® 55 Joulferon 55 topically applied SEPA 55 tasocitinib 55 Fortigel 55 SUTENT ® 55 Sandostatin LAR 55 Zenvia TM 55 Onbrez Breezhaler 54 TRELSTAR R 54 alvespimycin 54 mGluR5 negative 54 Ramelteon 54 PhosLo 54 lymphoma CTCL 54 Risperidone 54 ARIXTRA R 54 metformin HCl 54 Velcade bortezomib 54 biologic therapy 54 Abstral 54 systemic immunosuppressive drugs 54 Ticagrelor 54 Laquinimod 54 Avastin bevacizumab 54 Duloxetine 54 Denufosol 54 ONGLYZA 54 denufosol 54 TREANDA 54 Act PDUFA 54 mg/#.# mg [003] 54 Fast Track Status 54 Amoxicillin PULSYS 54 MAGE A3 ASCI 54 STELARA TM 54 INCB# [002] 54 Clevudine 54 REMINYL ® 54 Vimpat ® lacosamide 54 divalproex sodium 54 PSN# [002] 54 pediatric Crohn disease 54 Spiriva Handihaler 54 Zensana 54 phase IIb trial 54 Velaglucerase Alfa 54 neurogenic orthostatic hypotension 54 Tasimelteon 54 ACUROX 54 Nexavar sorafenib 54 XiDay 54 Exocrine Pancreatic Insufficiency 54 Orphan Status 54 Tablets #mg [001] 54 MyVax R 54 Ciclesonide 54 Hycamtin 54 5 HT3 antagonist 54 faropenem 54 Dasatinib 54 Rhucin ® 54 Afinitor ® 54 Phase 2a clinical 54 PMA Supplement 54 Full Prescribing Information 54 ATPace TM 54 Symbyax 54 JZP 54 primary hypercholesterolemia 54 rALLy clinical trial 54 Amlodipine Besylate Tablets 54 ANDA containing 54 Orphan Drug Designation 54 Somatuline R Depot 54 Prestara TM 54 Exelbine 54 AMITIZA R 54 Intuniv 54 HCV protease inhibitor 54 Oral Spray 54 granted Ortec 54 PROMUS Element Stent System 54 Investigational 54 Dyloject 54 investigational humanized monoclonal antibody 54 RSD# 54 sumatriptan injection 54 Simulect 54 cancer neuroendocrine tumor 54 Cimzia R 54 6R BH4 54 Xyzal R 54 LymphoStat B belimumab 54 Zidovudine Tablets 54 Phase 2a Trial 54 Darunavir 54 Phase 1b 54 opioid narcotic 54 low dose cytarabine 54 interferon beta 1b 54 Vidaza azacitidine 54 Serada 54 Hatch Waxman exclusivity 54 oral cladribine 54 5mg #mg #mg 54 Privigen 54 thetreatment 54 Ofirmev 54 Brentuximab Vedotin SGN 54 Focalin XR R 54 histone deacetylase HDAC inhibitor 54 POSIDUR TM 54 markets Gelclair R 54 arzoxifene 54 ANCHOR trial 54 Renvela ® 54 tablet formulation 54 testosterone gel LibiGel 54 TREDAPTIVE 54 vinorelbine tartrate 54 Folotyn 54 HUMIRA 54 phase IIa clinical 54 Preos 54 granulated mesalamine 54 abatacept 54 Xibrom QD 54 GAMMAGARD 54 Cloretazine ® 54 initiate Phase IIb 54 Investigational Oral 54 CHMP 54 Silenor NDA 54 Avanafil 54 losartan potassium 54 Noxafil 54 intranasal formulation 54 Nabi HB Intravenous 54 XOPENEX HFA MDI 54 Product Monograph 54 NGX# 54 Marketing Authorization 54 Linjeta TM 54 Benazepril 54 MoxDuo IR 54 ® decitabine 54 taliglucerase alfa 54 Orphan Drug 54 Tolvaptan 54 R vancomycin hydrochloride 54 EXALGO 54 Zavesca r 54 FDA Approval 54 rALLy 54 bremelanotide 54 Amlodipine Besylate 54 Phase IIa trials 54 Dementia Related Psychosis 54 XIBROM 54 PrandiMet TM 54 acyclovir Lauriad ® 54 phase III isavuconazole 54 Filgrastim 54 LEVADEX ™ 54 Sunovion 54 Voreloxin 54 ZEVALIN 54 carcinogenicity study 54 oral rivaroxaban 54 LUVOX CR 54 PRX # 54 Cloretazine 54 BROMDAY 54 GATTEX 54 EMBEDA ™ 54 VEGF Trap 54 oral anticoagulant 54 FACTIVE 54 Glycopyrrolate 54 Restanza 54 RG# [001] 54 ecallantide 54 BEMA TM LA 54 Drug Applications ANDAs 54 Vimpat lacosamide 54 baminercept 54 Leukine 54 Topotecan 54 EXPAREL ™ 54 mg Tablets 54 Contrave NDA 54 XL# anticancer compounds 54 balsalazide disodium Capsules 54 Release Tablets 54 Brovana 54 ZEGERID Powder 54 CONBRIZA 54 BCX# 54 Rasilez HCT 54 Zerenex 54 Phase III clinical trials 54 Cloretazine R VNP#M 54 Fortical R 54 ambrisentan 54 FASLODEX 54 ONCASPAR 54 R metformin Concor 54 LY# [003] 54 Completes Patient Enrollment 54 etravirine 54 eprodisate Fibrillex TM 54 ILUVIEN ® 54 #mg #mg [002] 54 oxycodone HCl 54 UPLYSO 54 Wellbutrin XL R 54 Cladribine 54 Emselex 54 non metastatic osteosarcoma 54 INCB# [001] 54 XAGRID 54 brand eszopiclone 54 AMEVIVE 54 idursulfase 54 Patient Enrollment 54 pixantrone NDA 54 paliperidone ER 54 IL# PE#QQR 54 CLARITY study 54 Phase 1a clinical 54 EFAPROXYN 54 Certolizumab pegol 54 Indiplon 54 IMPACT IMmunotherapy 54 REVLIMID R 54 Medicinal Products EMEA 54 Phase #/#a trial 54 intravenous formulation 54 ANDAs 54 FENTORA 54 BEMA ™ 54 KYNAPID 54 Synvisc One 54 Priority Review 54 TNF Tumor Necrosis Factor 54 Extavia 54 visilizumab 54 Ropinirole 54 ZYBRESTAT 54 CHMP recommendation 54 Presents Positive 54 RAPAFLO 54 Acetavance TM 54 Besivance 54 temsirolimus 54 Afinitor everolimus 54 ACUROX ® 54 Horizant 54 pan histone deacetylase 54 USFDA approval 54 Glucophage XR 54 Ophena TM 54 Xcytrin 54 ANDA filings 54 thymalfasin 54 fibromyalgia syndrome 54 rufinamide 54 lurasidone 54 Solzira 54 linagliptin 54 DU #b 54 zileuton CR 54 evaluating Actimmune 54 Betaferon ® 54 Proellex TM 54 phase IIb study 54 refractory APL 54 apremilast 54 Ondansetron Injection USP 54 Pixantrone 54 Opterone R 53 FOSRENOL 53 OMAPRO 53 Opana R 53 Kamada AAT 53 ENBREL 53 Ondansetron 53 APPRAISE 53 HepeX B TM 53 Pexeva 53 OROS R Hydromorphone 53 blinded randomized placebo controlled 53 Calcium Acetate 53 Saxagliptin 53 IPLEX 53 Dual Opioid 53 PROVENGE sipuleucel T 53 XIAFLEX ™ 53 BCR ABL inhibitor 53 Approvable letter 53 Androxal ® 53 COPAXONE R 53 Phase III placebo controlled 53 induced macular edema 53 sorafenib tablets 53 QAB# 53 Azilect 53 submitted Marketing Authorization 53 PLAVIX ® 53 Metformin GR 53 Bicifadine 53 CDP# 53 Drug Eluting Stent System 53 submitted supplemental Biologics 53 Topical Interferon Alpha 2b 53 Submits Supplemental 53 TRISENOX 53 Intermezzo R 53 initiated Phase Ib 53 Market Authorization Application 53 Pafuramidine 53 opioid induced constipation OIC 53 Resubmission 53 Cutaneous T 53 beta 1a 53 Bazedoxifene 53 ACTEMRA TM 53 phase IIa 53 Fusilev 53 Daliresp 53 LUVENIQ 53 HuMax CD4 53 PLK1 SNALP 53 Alvesco 53 Initiates Phase III 53 Bepreve 53 Phase IIb clinical 53 ALN HPN 53 Medoxomil 53 KRN# 53 Cleviprex TM clevidipine 53 Drug Application ANDA 53 tamibarotene