approvability

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(Click for frequent words.) 64 Lorqess 63 BLA filing 62 oral cladribine 62 Afrezza 62 oxymorphone ER 62 generic Copaxone 61 Nebido 61 Metabolic Drugs Advisory 61 Bifeprunox 61 generic Lovenox 60 SILENOR 60 FDA Advisory Panel 60 Oncologic Drugs Advisory 60 alogliptin 60 Kiacta 60 Complete Response 60 RIGScan CR 60 FM VP4 60 Egrifta 60 liprotamase 59 approvable letters 59 Byetta LAR 59 FDA approvable letter 59 Ambrisentan 59 Vidaza azacitidine 59 Intermezzo ® NDA 59 lasofoxifene 59 Zalbin 59 Kynapid 59 Orexigen Contrave 59 Dendreon Provenge 59 AZILECT R 59 Anti Infective Drugs 59 PREOS 59 alvimopan 59 SPARLON 59 bifeprunox 59 Orathecin 58 UPLYSO 58 Xinlay 58 ruxolitinib 58 Preos 58 guanfacine extended release 58 Velac 58 Serdolect 58 phentermine topiramate 58 Cladribine 58 MAA submission 58 FDA Complete Response 58 sitaxsentan 58 Ereska 58 desvenlafaxine 58 Hematide ™ peginesatide 58 exenatide LAR 58 MyVax 58 Luveris 58 FDA Endocrinologic 57 HCl capsules 57 sNDA submission 57 Gilenia 57 LibiGel ® 57 AERx iDMS 57 Krystexxa 57 Benlysta belimumab 57 severe gastroparesis 57 Pre IND 57 Androxal ® 57 MAGE A3 ASCI 57 Octreolin 57 Aveed 57 Iloperidone 57 CHMP recommendation 57 balsalazide tablet 57 Gralise 57 FDA Oncologic Drugs 57 Zelnorm Zelmac 57 PLAVIX ® 57 ticagrelor Brilinta 57 European Medicines Evaluation 57 Horizant 57 REMOXY NDA 57 Vilazodone 57 iloperidone 57 TBC# 57 CHMP 57 orBec 57 Linjeta 57 Bicifadine 57 Tekamlo 57 arzoxifene 57 AzaSite Plus 57 ULTRASE 57 Sanctura XR 57 dalbavancin 57 Biologics Licensing 57 Vertex hepatitis C 57 Afresa 57 sipuleucel T 57 gepirone ER 57 Joulferon 57 Biologic License Application BLA 57 PDUFA date 57 Novartis Galvus 56 baminercept 56 Zensana 56 FDA Approvable Letter 56 Promacta 56 Ophthalmic Drugs Advisory 56 AZILECT ® 56 Itopride 56 Fodosine 56 Bydureon 56 non selective NSAIDs 56 Vernakalant 56 tolevamer 56 approvable 56 Known hypersensitivity 56 Sebivo 56 MethyPatch 56 Vertex telaprevir 56 NDA resubmission 56 Lilly Cymbalta 56 RSR# 56 Sparlon 56 PhosLo 56 nalbuphine ER 56 Zarnestra 56 Risperidone Oral Solution 56 Nuedexta 56 elotuzumab 56 AstraZeneca Brilinta 56 BRILINTA 56 FIRMAGON R 56 gemifloxacin 56 NV1FGF 56 Focalin XR 56 Accelerated Approval 56 Trovax 56 efficacy tolerability 56 Linjeta TM 56 overlapping toxicities 56 Panzem R NCD 56 Plenaxis R 56 Pegloticase 56 Ofirmev 56 indiplon capsules 56 Ropinirole 56 renal toxicity 56 LAF# 56 Fablyn 56 efficacy 56 balsalazide 56 olanzapine LAI 56 Liraglutide 56 Arranon 56 muraglitazar 56 Syncria 55 Amlodipine Besylate 55 eprodisate Fibrillex TM 55 prucalopride 55 Febuxostat 55 Sanofi Aventis Taxotere 55 blood thinner prasugrel 55 Taxotere chemotherapy 55 Desmoteplase 55 TOLAMBA 55 tramiprosate ALZHEMED TM 55 CIP TRAMADOL ER 55 Rasilez HCT 55 sitaxsentan sodium 55 Vectibix panitumumab 55 Pfizer inhaled insulin 55 Ticagrelor 55 Tekturna HCT 55 Velcade bortezomib 55 pharmacokinetic interactions 55 Celgene Revlimid 55 interferon gamma 1b 55 Hyphanox 55 KRN# 55 INVEGA ® 55 Complete Response Letter 55 Neurodex 55 Marketing Authorisation Application 55 Dacogen injection 55 Pulmonary Allergy Drugs 55 tecarfarin 55 Pixuvri 55 vinflunine 55 eprotirome 55 Drug Eluting Stent System 55 unblind 55 Stavzor 55 EMBEDA 55 Galvus 55 Phenoptin 55 Provenge prostate cancer 55 Complete Response letter 55 Onsolis 55 lorcaserin NDA 55 ONGLYZA ™ 55 ARCOXIA 55 sitagliptin Januvia 55 Muraglitazar 55 Prosaptide 55 pancreatic enzyme replacement 55 PDUFA Date 55 Canvaxin 55 Endocrinologic 55 Targretin capsules 55 MyVax R 55 ezogabine 55 naronapride 55 Degludec 55 selective modulator 55 Bayer Xarelto 55 Psychopharmacologic Drugs Advisory 55 SinuNase 55 FACTIVE tablets 55 Combidex 55 HoFH 55 Entereg 55 Tredaptive 55 Romiplostim 55 LEP ETU 55 successfully commercialize Iluvien 55 teratogenicity 55 Novo Nordisk Victoza 55 anti arrhythmic 55 PIX# [002] 55 SILENOR ™ 55 CYP#A# inhibitor 55 QNEXA 54 PPAR agonist 54 zileuton CR 54 torezolid phosphate 54 glatiramer acetate 54 PegIntron 54 incyclinide 54 CONBRIZA 54 Centralized Procedure 54 Plicera 54 Diovan HCT 54 CRMD# 54 Pfizer respectfully disagrees 54 Zenvia ™ 54 FDA Dermatologic 54 Junovan 54 approvable letter 54 HuMax CD4 54 Zenpep 54 Certriad 54 Nuvion 54 postmarketing surveillance 54 Soriatane 54 Metformin GR 54 carcinogenicity studies 54 ixabepilone 54 hepatotoxicity 54 Adentri 54 Sanofi Acomplia 54 Fibrillex TM 54 phase IIb trial 54 Asentar 54 SILENOR TM 54 Phase Ib study 54 Vivus Qnexa 54 oral prodrug 54 Genz # 54 Icatibant 54 ONSOLIS 54 Aflibercept 54 Mycophenolate Mofetil 54 Board DSMB 54 bovine thrombin 54 pralatrexate 54 ZOLINZA 54 oral ridaforolimus 54 neratinib 54 adenosine injection 54 Puricase 54 tocilizumab 54 TWYNSTA ® 54 Product Monograph 54 Emezine 54 Soliris TM eculizumab 54 eltrombopag 54 DexaSite 54 Avanafil 54 midstage studies 54 anidulafungin 54 Allovectin 7 ® 54 Arxxant 54 Arcalyst 54 antiplatelet agent 54 Pennsaid R 54 pregabalin Lyrica 54 Fampyra 54 Joel Sendek 54 Pulminiq 54 Roche Actemra 54 faropenem 54 Sanvar 54 ISTODAX 54 Vectical TM Ointment 54 PIX# trial 54 paliperidone palmitate 54 Tasigna nilotinib 54 MoxDuo IR 54 Panzem R 54 ocrelizumab 54 ustekinumab 54 Firazyr 54 QLT# 54 Monane 54 pharmacokinetic PK study 54 Mirapexin 54 Avastin bevacizumab 54 SUCCEED trial 54 TLK# 54 Fibrillex 54 Prestara 54 PROVENGE ® 54 INCB# [001] 54 divalproex sodium 54 RhuDex 54 PSN# [002] 54 Amigal 54 Fast Track designations 54 Q#IR 54 antiarrhythmic 54 Fabry Disease 54 Exforge HCT 54 Geoffrey Porges 54 motavizumab 54 mg kg BID 54 parecoxib 54 Citizen Petition 54 Alimta pemetrexed 54 erlotinib Tarceva 54 desvenlafaxine succinate 54 Merck boceprevir 54 TELINTRA 54 sorafenib Nexavar 54 ICA # 54 Premarket Approval 54 antidepressant efficacy 54 IRESSA 54 otelixizumab 54 heterozygous FH 54 Targretin 54 bosutinib 54 injectable formulations 54 ganetespib 54 efalizumab 54 alemtuzumab MS 54 Indiplon 54 BiDil XR 54 Zavesca 54 ACCLAIM II 54 Ocrelizumab 54 rALLy trial 54 surrogate endpoint 54 Technosphere Insulin 54 Entereg R 53 Increlex R 53 cladribine 53 postoperative ileus POI 53 ATACAND 53 amrubicin 53 Anidulafungin 53 ponatinib 53 Marketing Authorisation Application MAA 53 amifostine 53 azficel T 53 Aplenzin ™ 53 Advagraf 53 IL# PE#QQR 53 DORIBAX 53 aflibercept 53 antifibrinolytic 53 BAL# [002] 53 clevidipine 53 Novartis Prexige 53 zalutumumab 53 DPP4 53 Ketotransdel 53 pomalidomide 53 Onrigin 53 Emselex 53 postapproval 53 canakinumab 53 acitretin 53 Phase IIb trials 53 Pivotal Phase III 53 Pimavanserin 53 ZEGERID Chewable Tablets 53 peginesatide 53 limiting toxicity DLT 53 Sensipar 53 prGCD 53 ruboxistaurin 53 lomitapide 53 Announces Tentative Approval 53 nonclinical studies 53 midodrine 53 ACCORD Lipid 53 Pruvel 53 Exalgo 53 vidofludimus 53 metoprolol succinate 53 CDP# 53 PDUFA 53 AVASTIN 53 tolerability profiles 53 reslizumab 53 T Pred 53 carcinogenicity 53 ambrisentan 53 Prexige lumiracoxib 53 therapeutic equivalence 53 abatacept Orencia 53 Nexavar sorafenib 53 Panitumumab 53 FDA 53 BYETTA exenatide injection 53 aclidinium 53 Ketotransdel ® 53 SPRYCEL ® 53 trastuzumab DM1 53 Merck Arcoxia 53 vismodegib 53 Medicinal Products EMEA 53 Arthritis Advisory 53 GALNS 53 analyst Geoffrey Meacham 53 FDA Psychopharmacologic Drugs 53 pioglitazone HCl 53 ReFacto 53 Telintra 53 AstraZeneca Iressa 53 BEMA TM Fentanyl 53 celgosivir 53 Spiegelmer ® 53 oxaliplatin Eloxatin 53 bicifadine 53 Dyloject TM 53 Augment ™ Bone Graft 53 palifosfamide 53 SUTENT ® 53 antiarrhythmic drug 53 KIACTA ™ 53 bevacizumab Avastin Genentech 53 LibiGel NDA 53 Zenvia 53 efficacy endpoint 53 Orencia abatacept 53 Sycrest 53 investigational hepatitis B 53 Aceon 53 riociguat 53 severe hypercholesterolemia 53 DPP4 inhibitor 53 BLA submission 53 asenapine 53 Qnexa 53 lucinactant 53 preclinical pharmacokinetic 53 Approvable Letter 53 Teveten 53 SmPC 53 Revlimid lenalidomide 53 Arena lorcaserin 53 Ceflatonin 53 mifamurtide 53 TNF inhibitor 53 generic gabapentin 53 vandetanib 53 Phase IIB 53 Elocalcitol 53 PROVIGIL 53 Drug Administration Oncologic Drugs 53 Cory Kasimov 53 GLP toxicology studies 53 Archexin 53 Corlux 53 torsemide ER 53 Cinryze ™ 53 Vimpat R 53 oral antiplatelet 53 Biologic License Application 53 Roflumilast 53 Troxatyl TM 53 methylnaltrexone 53 thienopyridine 53 IMA# 53 Orapred ODT 53 glatiramer 53 Hectorol R 53 Acetavance 53 EVIZON 53 MK #B 53 Civacir 53 SinuNase TM 53 Bioequivalence 53 Arzerra ofatumumab 53 Trexima 53 bazedoxifene 53 Tarceva TM 53 hylan GF 53 Femara letrozole 53 Lu AA# 53 Amyvid 53 Viramidine 53 valvulopathy 53 Solzira 53 VIAject 53 Frova ® 53 Auxilium Pharma 53 clinical endpoints 53 IFN β 53 indacaterol 53 gadobutrol 53 Telavancin 53 Byetta exenatide 53 troglitazone 53 Telaprevir 53 PEG PAL 53 Amgen Prolia 53 FDA Anti Infective 53 fingolimod 53 Dalbavancin 53 National Coverage Determination 53 dexanabinol 53 Proquin XR 52 pulls Darvon painkiller 52 coadministration 52 MEVACOR 52 ELIQUIS 52 Nabi HB Intravenous 52 Folotyn 52 Silodosin 52 Glybera R 52 cinacalcet HCl 52 mRCC 52 pamidronate 52 Zocor simvastatin 52 figitumumab 52 GSK# [001] 52 citalopram hydrobromide 52 REMINYL ® 52 octreotide acetate 52 JAK inhibitor 52 OvaRex R 52 Replagal 52 Zyprexa LAI 52 Menerba 52 Ranolazine 52 Ophena TM 52 MERLIN TIMI 52 Cinquil 52 Heplisav 52 sNDA filing 52 Product Characteristics 52 Zyflo CR 52 VIAject R 52 PrandiMet TM 52 Cloretazine 52 Genzyme Myozyme 52 orphan medicinal product 52 pirfenidone 52 pharmacoeconomic 52 Complete Response Letter CRL 52 ACUROX ® 52 Mitigation Strategy REMS 52 Joshua Schimmer 52 biosimilar versions 52 Doribax 52 Raptiva ® 52 Plenaxis TM 52 Zentase 52 Preotact 52 Fanapt ™ 52 ATPace TM 52 Telzir 52 liraglutide 52 generic Vancocin 52 Stedesa 52 Tygacil 52 Cimzia TM 52 optimal dosing 52 tanespimycin 52 QAB# 52 Flutiform TM 52 UCB Cimzia 52 NOXAFIL 52 Teriparatide 52 Synavive 52 vildagliptin 52 blood thinner Xarelto 52 Abilify aripiprazole 52 autologous cellular immunotherapy 52 BENLYSTA 52 galiximab 52 aripiprazole Abilify 52 NEBIDO 52 Trobalt 52 Cenestin 52 indiplon 52 Zoraxel 52 Oglemilast 52 Orazol 52 naltrexone bupropion 52 PXD# 52 Keppra XR 52 aleglitazar 52 CIP ISOTRETINOIN 52 apremilast 52 DCCR 52 selective A2A adenosine receptor 52 torcetrapib atorvastatin 52 Drug Administration FDA Oncologic 52 Serada 52 hoFH 52 REBETOL combination therapy 52 Starlix 52 cetuximab Erbitux 52 Valtropin 52 brivaracetam 52 ImClone Erbitux 52 cangrelor 52 Linjeta ™ 52 postoperative ileus 52 iniparib 52 Troxatyl 52 Onconase 52 AVADO 52 Androxal TM 52 Polymeropoulos 52 IBS C 52 valdecoxib 52 rabeprazole sodium 52 enzastaurin 52 Tyvaso 52 Amylin Eli Lilly 52 Milnacipran 52 Vancocin 52 SANVAR 52 Act PDUFA date 52 Cintredekin besudotox 52 rilonacept 52 PMA submission 52 posaconazole 52 histamine dihydrochloride 52 Surfaxin lucinactant 52 Contrave 52 Rhucin ® 52 Galida 52 Zybrestat 52 tasocitinib 52 unblinding 52 metaglidasen 52 HGS ETR2 52 Exelixis compounds 52 investigational antiplatelet agent 52 AEGR 52 ASCEND HF 52 antidiabetic drug 52 Approvable 52 Pfizer Exubera 52 Orphan Status 52 panitumumab Vectibix 52 cannabinor 52 QT prolongation 52 UCB Keppra 52 rasagiline tablets 52 OMAPRO ™ 52 Stavzor TM 52 motesanib 52 Fanapt TM 52 Dr. Pazdur 52 LymphoStat B 52 Cancidas 52 Saphris 52 hypersensitivity allergic reactions 52 Treximet 52 Bonefos 52 Trasylol aprotinin 52 GlaxoSmithKline Plc diabetes 52 Effexor venlafaxine 52 Nasdaq OSCI 52 EGRIFTA 52 STELARA TM 52 casopitant 52 COX 2s 52 Toremifene 52 Loxapine 52 Bepreve 52 candidates Dyloject TM 52 PROTONIX 52 AIDAC 52 Zegerid OTC 52 Arixtra 52 Aciphex R 52 Resubmission 52 Onbrez Breezhaler 52 Wellbutrin XL ® 52 intravenous acetaminophen 52 valopicitabine 52 Glufosfamide 52 antiviral efficacy 52 QVA# 52 receptor inhibitor 52 pseudobulbar affect PBA 52 noninferiority 52 FASLODEX 52 Mipomersen 52 APPRAISE 52 mapatumumab 52 APTIMA HPV assay 52 potency selectivity 52 PrevOnco 52 Fluconazole 52 Dyloject 52 ICH guidelines 52 Potiga 52 iclaprim 52 talactoferrin 52 hypercalcemia 52 R# #mg BID 52 docetaxel emulsion 52 forodesine 52 Pfizer maraviroc 52 virus HCV protease inhibitor 52 CINQUIL 52 Tavocept 52 tremelimumab 51 Cellegesic 51 ENTEREG ® 51 orally disintegrating 51 platelet inhibitor 51 Amylin Byetta 51 MEDCAC 51 Proleukin 51 Lenalidomide 51 mesylate 51 Raptiva R 51 Januvia sitagliptin 51 vemurafenib 51 Votrient 51 Brilique 51 Eli Lilly Cymbalta 51 Kuvan 51 Santhera 51 Marketing Authorization Application 51 Exelbine 51 Ilaris 51 R sipuleucel T 51 Aviptadil 51 Subpart H 51 Safinamide 51 Pazopanib 51 pain palliation 51 GLP1 agonist 51 pharmacokinetic PK profile 51 Ceplene 51 SIMPADICO trial 51 MGN# 51 pharmacokinetic characteristics 51 Fanapt 51 Paliperidone Palmitate 51 Factive 51 Zenvia Phase III 51 Remicade infliximab 51 Stelara 51 EOquin TM 51 SNT-MC#/idebenone 51 nebivolol 51 CETP inhibition 51 Alogliptin 51 FROVA 51 Desvenlafaxine 51 lenalidomide Revlimid 51 CHMP opinion 51 Aplenzin 51 Adventrx 51 Phase IIb III 51 Omigard 51 Intravitreal 51 Noxafil 51 Cefprozil 51 SPIRIVA HandiHaler 51 Ixempra 51 BrachySil 51 Sulonex 51 PRT# 51 ganaxolone 51 Leukine 51 PDE4 inhibitors 51 febuxostat 51 mitochondrial toxicity 51 AstraZeneca Seroquel 51 etanercept Enbrel 51 Serdolect ® 51 quetiapine fumarate 51 Berinert 51 Marketing Authorization Applications 51 PDUFA Prescription Drug 51 cardiac toxicity 51 PEGylated interferon beta 1a 51 Pemetrexed 51 NATRECOR ® 51 FOLOTYN ® 51 Tablets #mg [001] 51 CIP Fenofibrate 51 GLYX 51 zanolimumab 51 neuropsychiatric adverse 51 sumatriptan injection 51 Sumatriptan Succinate 51 pharmacokinetic parameters 51 Zolpimist 51 recombinant thrombin 51 NDA submission 51 cladribine tablets 51 intravitreal implant 51 pioglitazone Actos 51 TOPROL XL 51 teriflunomide 51 PDE4 inhibitor 51 Myfortic 51 Reclast Aclasta 51 EFAPROXYN 51 AIR Insulin 51 Irinotecan Hydrochloride Injection 51 USL# 51 Submits NDA 51 Pirfenidone 51 Gemzar gemcitabine 51 LymphoStat B TM 51 Fulvestrant 51 EDEMA3 51 PTK ZK 51 Enjuvia 51 Dasatinib 51 TRADJENTA 51 AstraZeneca Symbicort 51 Tolamba 51 Geoffrey Meacham 51 Factor VIIa 51 paliperidone ER 51 Uvidem 51 linagliptin 51 prasugrel 51 vernakalant hydrochloride 51 Zelrix 51 phase IIb clinical 51 lisdexamfetamine dimesylate 51 TREDAPTIVE 51 pharmacokinetic equivalence 51 reboxetine 51 Uplyso 51 Omnitrope 51 romiplostim 51 Encysive Pharmaceuticals Nasdaq ENCY 51 HyQ 51 maximally tolerated dose 51 Somatuline R Autogel R 51 midstage clinical 51 ACZ# 51 lumiliximab 51 Orphan Designation 51 OraTest 51 EMBEDA ™ 51 Azedra TM 51 Tesamorelin 51 tipranavir 51 AIM HIGH 51 investigational compound 51 Torisel 51 LY# [002] 51 Tezampanel 51 Rasagiline 51 ORENCIA R 51 Oporia 51 temsirolimus 51 Relovair 51 PROMACTA 51 dual endothelin receptor antagonist 51 Human Medicinal Products 51 #D#C# 51 Vasovist 51 ADAGIO study 51 Exalgo TM 51 Effient prasugrel 51 Octreotide 51 Tasimelteon 51 solanezumab 51 refractory gout 51 Application BLA 51 Symbyax 51 5mg #mg #mg 51 Glatiramer Acetate 51 Dexilant 51 Antiviral Drugs Advisory 51 Rebif ® 51 gabapentin enacarbil 51 FDA Antiviral Drugs 51 ENHANCE trial 51 Orphan Drug designations 51 Celebrex celecoxib 51 clinical trials 51 zafirlukast 51 hepatic toxicity 51 intravenous formulations 51 Vibativ 51 KRAS status 51 rhIGF 1 51 Not Approvable 51 Pharmacokinetic 51 TYKERB 51 Zerenex 51 Aliskiren 51 SAPHRIS 51 MAXY alpha 51 Zactima 51 Balaglitazone 51 FACTIVE R gemifloxacin 51 Rotarix ® 51 POSIDUR TM 51 levocetirizine 51 orphan designation 51 pertuzumab 51 Fusilev 51 Stalevo 51 6R BH4 51 Dynepo 51 Asenapine 51 comparator arm 51 pharmacodynamic properties 51 Nebivolol 51 Stent thrombosis 51 ALGRX 51 pradefovir 51 phase IIb III 51 HepaGam B 51 Kaletra lopinavir ritonavir 51 Adalimumab 51 Regeneron Pharma 51 Teysuno 51 urate lowering 51 CAPHOSOL 51 HuMax EGFr 51 Triapine R 51 ZEGERID Capsules 51 Xanafide 51 Injectafer 51 Actoplus Met 51 relapsed MCL 51 Diamyd r 51 ISENTRESS 51 arbaclofen 51 Actimmune R 51 contraindicate 51 paroxetine sertraline 51 atacicept 51 Cerepro 51 Cefazolin 51 Vyvanse lisdexamfetamine dimesylate 51 Novartis Gilenia 51 EMBEDA TM 51 Gaboxadol 51 almorexant 51 Pravastatin 51 Onglyza 51 Lilly Evista 51 rThrombin 51 clazosentan 51 Vioxx Sharfstein 51 XIAFLEX ™ 51 antidiabetic drugs 51 MBP# [001] 51 Arzerra 51 LDL lowering 51 pharmacodynamic effects 51 ELND# 51 liposomal formulation 51 Prilosec omeprazole 51 TYZEKA 51 BENLYSTA ® 51 albinterferon alfa 2b 51 telcagepant 50 etravirine 50 EndoTAG TM -1 50 Glybera 50 FDA Accepts 50 Multiple Ascending Dose 50 alglucosidase alfa 50 Tolvaptan

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