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(Click for frequent words.) 73 Prescription Drug User Fee 73 Act PDUFA 71 PDUFA date 64 PDUFA Prescription Drug 63 User Fee Act 61 Act PDUFA date 56 NDA resubmission 56 FDA 55 Priority Review 54 pediatric exclusivity 54 FDAAA 54 PDUFA Date 53 MDUFMA 53 NDA submission 53 approvable letters 53 approvability 53 Biologics Licensing 53 Accelerated Approval 52 FDA Advisory Panel 52 CDER 52 Biologics License Application BLA 52 FDA Modernization Act 52 Hatch Waxman 52 Premarket Approval 51 alogliptin 51 Complete Response 51 BLA submission 51 eprodisate Fibrillex TM 51 BLA filing 51 indiplon capsules 51 alvimopan 50 metoprolol succinate 50 Biologics License Application 50 assigned PDUFA 50 FDA approvable letter 50 Drug Administration FDA 50 sNDA 50 MethyPatch 50 dalbavancin 50 Biologic License Application BLA 50 Orexigen Contrave 50 lorcaserin NDA 50 EMBEDA 50 Voraxaze 50 ONGLYZA ™ 50 FDA Complete Response 50 Subpart H 50 Exalgo 50 generic biologic 50 Cladribine 50 Nuedexta 50 REMS 50 QNEXA 49 QbD 49 SEASONIQUE 49 Intermezzo ® NDA 49 ANDA filings 49 HCl capsules 49 BRILINTA 49 Pre IND 49 biosimilar 49 PREOS 49 torezolid phosphate 49 Hatch Waxman Amendments 49 PMPRB 49 postmarketing studies 49 injectable formulations 49 ANDAs 49 Paragraph IV 49 Lorqess 49 Bydureon 49 Nebido 49 Q#IR 48 EMBEDA ™ 48 PhosLo 48 ISTODAX 48 Provenge prostate cancer 48 ZEGERID Chewable Tablets 48 LUVOX CR 48 RIGScan CR 48 Emezine 48 Rhucin ® 48 Cethromycin 48 ZEGERID Capsules 48 Linjeta 48 MAA submission 48 OLEPTRO 48 Orathecin 48 Gestiva TM 48 NEBIDO 48 Biologic License Application 48 telavancin NDA 48 CIP TRAMADOL ER 48 NMEs 48 Mitigation Strategy REMS 48 sNDA filing 48 Kynapid 48 zileuton CR 48 Zalbin 48 Drug Administration Amendments 48 Onsolis 48 IND submission 47 COLAZAL 47 Marketing Authorization Application 47 New Drug Application 47 generic Flomax 47 Gralise 47 Dalbavancin 47 Metabolic Drugs Advisory 47 Telavancin 47 Zenpep 47 Complete Response Letter CRL 47 balsalazide tablet 47 Complete Response Letter 47 ANDA filer 47 Risperidone Oral Solution 47 CHMP recommendation 47 GRALISE 47 Preotact 47 Cefazolin 47 Hatch Waxman Act 47 Dendreon Provenge 47 biogeneric drugs 47 generic Lovenox 47 FDA Orphan Drug 47 Anti Infective Drugs 47 Stavzor 47 PMA submission 47 postapproval 47 Afrezza 47 Krystexxa 47 FDA Oncologic Drugs 47 peginesatide 47 WHO prequalification 47 balsalazide 47 naproxen esomeprazole magnesium 47 cethromycin NDA 47 NUVIGIL 47 premarket notification 47 Arzerra ofatumumab 47 Surfaxin lucinactant 47 Intuniv 47 CHMP 47 Captisol enabled 47 Firazyr 47 NitroMist TM 47 molecular entities NMEs 47 Contrave NDA 47 Tekturna HCT ® 46 Marketing Authorisation 46 Horizant 46 GLP1 agonist 46 Oncologic Drugs Advisory 46 REMOXY NDA 46 Focalin XR 46 Subpart E 46 ARCOXIA 46 ixabepilone 46 sNDAs 46 Neurodex 46 rabeprazole sodium 46 Marketing Authorisation Application MAA 46 Emend 46 tramiprosate ALZHEMED TM 46 Targretin capsules 46 Sanctura XR 46 ULTRASE 46 Optimer Pharma 46 Promacta 46 Zytiga 46 cGMPs 46 SPARLON 46 oxymorphone ER 46 Vilazodone 46 CERVARIX R 46 GMPs 46 M Enoxaparin 46 FDA Endocrinologic 46 Somatuline R Autogel R 46 APF# NDA 46 ANDA applicant 46 ACUROX ® 46 European Medicines Evaluation 46 INDs 46 biogeneric 46 Lumizyme 46 Celgene Revlimid 46 Opana ER 46 OraTest 46 rALLy trial 46 Byetta LAR 46 hylan GF 46 paliperidone palmitate 46 Felodipine 46 MIPPA 46 Critical Path Initiative 46 Civacir 46 Plenaxis R 46 Glumetza 46 Complete Response letter 46 Mitigation Strategies REMS 46 METOZOLV ODT 46 XIAFLEX ™ 46 Premarket Approval Application 46 SEASONALE 46 Kiacta 45 Centralized Procedure 45 T Pred 45 supplemental Biologics License Application 45 Focalin XR R 45 Biosimilars 45 Gestiva ™ 45 TWYNSTA ® 45 FDA Anti Infective 45 Par Pharma 45 NAMENDA 45 Dexilant 45 Tyvaso 45 pixantrone NDA 45 approvable 45 Trexima 45 Contrave 45 Research CBER 45 PROVIGIL 45 Expedited Review 45 orphan drug 45 Plicera 45 5mg #mg #mg 45 biogenerics 45 Dacogen injection 45 Syncria 45 Drug Applications ANDAs 45 Ramelteon 45 Alvesco R 45 divalproex sodium 45 Zolpimist 45 GPhA 45 INTUNIV TM 45 Arena Pharmaceuticals ARNA 45 Clolar 45 MNKD 45 generic Norvasc 45 FDAs 45 BioDelivery Sciences 45 Omnitrope 45 Barr ANDA 45 Xibrom QD 45 Arzerra 45 approvable letter 45 Icatibant 45 Somatuline Depot 45 fluvoxamine maleate 45 postmarketing surveillance 45 Nabi HB Intravenous 45 Dificid 45 eCTD format 45 Febuxostat 45 Fast Track designations 45 Frova R 45 Cubicin 45 methylnaltrexone 45 Orphan Status 45 Zelrix 45 Anidulafungin 45 FACTIVE R gemifloxacin 45 Medicinal Products EMEA 45 Velcade bortezomib 45 FDA Approvable Letter 45 Research CDER 45 Silenor NDA 45 Frova ® 45 MoviPrep 45 ISO Vorin TM 45 Xinlay 45 Cinryze 45 REMINYL ® 45 ALGRX 45 Strativa 45 Indiplon 45 LDTs 45 OraTest R 45 PIX# trial 45 Tasigna nilotinib 45 Oracea 45 MK #B 45 Entereg 45 Emezine R 45 authority Gurian Sherman 44 Drug Administration Oncologic Drugs 44 Exforge HCT 44 Ticagrelor 44 ATryn ® 44 AVNR 44 Celebrex celecoxib 44 Acurox r Tablets 44 DAYTRANA TM 44 gave Makena orphan 44 Vimovo 44 Zensana 44 APTIMA HPV assay 44 paliperidone ER 44 SURFAXIN 44 QCOR 44 ANDA 44 orBec 44 application sNDA 44 Metformin GR 44 Metformin Hydrochloride 44 Exelbine 44 OvaDx 44 ezogabine 44 Wellbutrin XL R 44 Afresa 44 sBLA 44 oral cladribine 44 DPP4 inhibitor 44 Amrix 44 Act PDUFA guidelines 44 Gestiva 44 Advagraf 44 Orphan Drug Act 44 docetaxel emulsion 44 Kuvan 44 BioThrax ® 44 guanfacine extended release 44 Pfizer Exubera 44 Orphan Designation 44 Amlodipine Besylate Tablets 44 sNDA submission 44 Exelbine NDA 44 ATryn R 44 Orapred ODT 44 generic Copaxone 44 desvenlafaxine 44 APRISO 44 alemtuzumab MS 44 Cefdinir 44 postmarket surveillance 44 Alnara 44 Somatuline Autogel 44 R sipuleucel T 44 oral ridaforolimus 44 Viibryd 44 Citizen Petition 44 SILENOR 44 Xifaxan 44 supplemental biologics 44 propoxyphene containing 44 Hematide ™ peginesatide 44 ENRICH trial 44 Amlodipine Besylate 44 NeutroSpec 44 Hectorol R 44 Benazepril 44 cycle oral contraceptive 44 Lilly Cymbalta 44 Bepreve 44 Fast Track designation 44 ENTEREG ® 44 orphan designation 44 CigRx TM 44 USFDA 44 sumatriptan injection 44 Preos 44 Plenaxis TM 44 #mg dosage strength 44 TNF blocker 44 SEASONALE R 44 generic Lipitor 44 biosimilars 44 Auxilium Pharma 44 Certriad 44 URG# 44 Daytrana TM 44 Sanofi Acomplia 44 Omapro 44 prGCD 44 Genzyme Myozyme 44 CDRH 44 granted Ortec 44 granulated mesalamine 44 PLAVIX ® 44 BiDil XR 44 Drug Administration 44 Prostate AdenoCarcinoma Treatment 44 Orphan Drug designations 44 Caduet 44 TYGACIL 44 Reclast Aclasta 44 Kombiglyze XR 44 ONSOLIS 44 Fibrillex 44 Flutiform ™ 44 oxycodone HCl 44 Enjuvia 44 Zarnestra 43 ANDA approvals 43 Panzem R NCD 43 MHPAEA 43 reapproval 43 FDA Accepts 43 IU vial 43 VALSTAR 43 Sanofi Aventis Acomplia 43 Standards CFATS 43 Acurox ® 43 generic biologics 43 anidulafungin 43 milligram capsule 43 ER oxymorphone hydrochloride 43 PHD Orders 43 MyVax 43 Tekturna HCT 43 MDCO 43 AZILECT R 43 unapproved colchicine 43 Dr. Gulfo 43 Sprycel dasatinib 43 EXALGO 43 RAPTIVA 43 alogliptin NDA 43 Marketing Authorization 43 Ropinirole 43 capsules USP 43 Egrifta 43 Riluzole 43 Genz # 43 MAGE A3 ASCI 43 clopidogrel bisulfate 43 Symbyax 43 Helixate FS 43 PMA Supplement 43 DORIBAX 43 Encysive Pharmaceuticals Nasdaq ENCY 43 Release Capsules 43 FOSRENOL R 43 Tygacil 43 HuMax CD4 43 Bioequivalence 43 allergen labeling 43 Fusilev 43 alglucosidase alfa 43 Allegra D# 43 Victoza 43 Sumatriptan Succinate 43 PROVENGE ® 43 Zebinix R 43 Corlux 43 MHLW 43 Glucophage XR 43 TIMERx 43 autologous cellular immunotherapy 43 BENLYSTA ® 43 FDA Accelerated Approval 43 Application BLA 43 DepoMed 43 ANDAs pending 43 Chemical Entity NCE 43 #mg #mg [002] 43 Octreotide 43 nonclinical studies 43 nasal calcitonin product 43 pancreatic enzyme replacement 43 Pulmonary Allergy Drugs 43 Kapidex 43 Junovan 43 ICH guidelines 43 rilonacept 43 Megace R ES 43 Xgeva 43 Pfizer maraviroc 43 Aplenzin 43 Ixempra 43 Psychopharmacologic Drugs Advisory 43 AstraZeneca Symbicort 43 DIFICID 43 lanthanum carbonate 43 MEND CABG II 43 oral taxane 43 MGCD# clinical trials 43 BeneFIX 43 DCGI 43 BrachySil 43 TWYNSTA 43 Oleptro 43 darbepoetin alfa Aranesp 43 Flutiform TM 43 Sanvar R 43 DORYX 43 FIRAZYR 43 octreotide acetate 43 orphan medicinal product 43 Eli Lilly Cymbalta 43 Metozolv ODT 43 bifeprunox 43 Coreg CR 43 Applications ANDA 43 Nascobal 43 Biaxin XL 43 Pliaglis 43 Orphan designation 43 Metoprolol Succinate 43 anagrelide 43 SCOLR Pharma 43 enoxaparin sodium injection 43 Daytrana ™ 43 OPANA ER 43 eliglustat tartrate 43 Folotyn 43 USL# 43 Moxatag 43 Premarket Approval PMA 43 Exalgo TM 43 oral mesalamine 43 buccal tablets 43 PROTONIX 42 Muraglitazar 42 LibiGel NDA 42 Luvox CR 42 Noxafil 42 Devices Advisory Panel 42 Pennsaid R 42 BEMA TM Fentanyl 42 NASPER 42 Xarelto rivaroxaban 42 eMDR 42 Cinryze ™ 42 postmarket safety 42 rhThrombin 42 Investigational 42 Vidaza azacitidine 42 ruxolitinib 42 SOLODYN 42 Announces Tentative Approval 42 Biologics License Applications 42 Zyflo CR 42 DEXILANT 42 INVEGA ® 42 Zelapar 42 Marketing Authorisation Application 42 DepoDur TM 42 surrogate endpoint 42 Viviant 42 Approvable 42 Cardene 42 Tamsulosin 42 MK #A [001] 42 Tramadol ER 42 release guaifenesin 42 DPCO 42 Rapaflo 42 Torisel 42 Cellegesic 42 PRISTIQ 42 Drug Eluting Stent System 42 Ereska 42 Drug Submission 42 sitagliptin Januvia 42 Toremifene 42 VIMOVO 42 oral rivaroxaban 42 Stelara 42 Octreolin 42 Aegerion 42 Cerepro ® 42 HepaGam B 42 Acurox 42 maximally tolerated dose 42 Stavzor TM 42 Hatch Waxman exclusivity 42 fusion inhibitor 42 Zipsor 42 Fortical R 42 Ofirmev 42 Orphan Drug Designation 42 Drug Application 42 MONOVISC 42 PPACA 42 exenatide Byetta 42 Doribax 42 orphan medicinal 42 GRAS affirmation 42 NOPR 42 OvaRex R 42 ImClone Erbitux 42 Avanir Pharma 42 pseudobulbar affect PBA 42 urokinase 42 Frova 42 Evamist TM 42 Tekturna Rasilez 42 pregabalin Lyrica 42 Cefprozil 42 Abilify aripiprazole 42 Liprotamase 42 Rhucin R 42 Drug Administration Modernization Act 42 SUMAVEL 42 bazedoxifene 42 Lamictal ODT 42 ANDAs pending approval 42 PIX# [002] 42 ZEGERID OTC 42 DDMAC 42 Loxapine 42 Fibrillex TM 42 mg usa 42 XIBROM 42 biosimilar versions 42 AzaSite Plus 42 Nebivolol 42 Communications DDMAC 42 Onrigin 42 dispositive motions 42 Linjeta TM 42 dosage regimen 42 Pixuvri 42 Progenics Pharmaceuticals 42 Bupropion HCl ER 42 TRISENOX 42 JEANIE SENIOR Issue 42 dosing frequency 42 carcinogenicity studies 42 Encysive 42 Nasdaq OSCI 42 Montelukast 42 Drug Applications NDAs 42 Treximet 42 biologics 42 cefepime 42 Galvus 42 CoFactor 42 mesylate tablets 42 ONCONASE R 42 lasofoxifene 42 Amgen Prolia 42 Orthopedic Advisory Panel 42 Soliris TM eculizumab 42 Zavesca 42 ZEGERID Powder 42 Requip XL 42 Zegerid OTC 42 antiinfective 42 hoFH 42 Feraheme ® 42 Rasagiline 42 faropenem 42 Novartis Galvus 42 Bayer Onyx 42 inhalable insulin product 42 metformin HCl 42 lucinactant 42 Solzira 42 refractory APL 42 Removab 42 FROVA 42 Renvela 42 Vandetanib 42 liver resection surgeries 42 EFFECTIVE DATE 42 Increlex TM 42 Issues Complete Response 42 Zentase 42 Megace ES 42 Invega 42 AERx iDMS 42 LIALDA 42 Ariva BDL 42 Bifeprunox 42 QNEXA ® 41 Cancidas 41 Orazol 41 tolevamer 41 ATPace TM 41 Avinza 41 liprotamase 41 Impax generic 41 severe gastroparesis 41 Act FDAAA 41 loratadine 41 Amoxicillin Pulsys 41 RECOTHROM R 41 Exanta 41 Lidoderm 41 Ferumoxytol 41 Mylotarg 41 Joulferon 41 SPRIX ® 41 pioglitazone HCl 41 Welchol 41 Ampligen 41 filgrastim 41 ASACOL 41 InvaGen 41 Unifill syringe 41 Lumacan 41 Metformin HCl 41 ketolide antibiotic 41 Paragraph IV certifications 41 trospium chloride 41 metformin hydrochloride tablets 41 Relistor 41 donepezil hydrochloride 41 RANK Ligand inhibitor 41 tecarfarin 41 NOXAFIL 41 PDUFA reauthorization 41 Vectibix panitumumab 41 successfully commercialize Iluvien 41 AdreView 41 blood thinner prasugrel 41 midodrine 41 OLEPTRO ™ 41 Evoltra 41 torsemide ER 41 Danazol 41 levalbuterol 41 Stonewall BDL 41 carcinogenicity study 41 Contrave# 41 sumatriptan succinate 41 Augment Bone Graft 41 Receives Tentative FDA 41 Arcalyst 41 KYNAPID 41 Sensipar 41 Zingo TM 41 Vimpat R 41 Inhaled insulin 41 Teva ANDA 41 ACIPHEX 41 Esbriet pirfenidone 41 Rotarix ® 41 ONXX 41 Orexigen 41 Fodosine 41 NerPharMa 41 SEASONIQUE R 41 omeprazole sodium bicarbonate 41 Fampridine SR NDA 41 Livalo 41 file INDs 41 Thyrogen 41 Piperacillin 41 Gamunex C 41 Entocort 41 amlodipine besylate 41 Novartis Prexige 41 Copayments 41 Shire Adderall XR 41 fentanyl transdermal system 41 CLIA waived status 41 anagrelide hydrochloride 41 ANTEGREN 41 Saphris 41 Medicinal Products 41 NDAs 41 Reinspection 41 GRAS status 41 methylphenidate HCl 41 ustekinumab 41 mesylate tablets approved 41 Natroba 41 CIP ISOTRETINOIN 41 Vertex hepatitis C 41 midstage studies 41 inspectional observations 41 capsule formulation 41 endoscopic gastric ulcers 41 daily Glumetza TM 41 markets HP Acthar 41 ATryn 41 cefuroxime axetil 41 eligen ® 41 Board DSMB 41 venlafaxine hydrochloride 41 Not Approvable 41 IND CTA 41 Merck Januvia 41 Medidur TM FA 41 Synera 41 Galida 41 Adcirca 41 oral anticoagulant 41 Grandfathered Plan 41 Amgen Nplate 41 Stedesa 41 Zirgan 41 ABILIFY ® 41 SEASONIQUE TM 41 anti emetic 41 VIAject 41 Glumetza TM 41 Protalix BioTherapeutics 41 regorafenib 41 Marketing Authorization Application MAA 41 Genzyme Synvisc 41 EGRIFTA TM 41 pancreatic enzyme 41 Methylin 41 Javelin Pharmaceuticals AMEX JAV 41 Vfend 41 Silenor ® doxepin 41 NESINA 41 Altabax 41 POZN 41 Syntonix 41 BioTie 41 Aloxi Injection 41 Velaglucerase Alfa 41 Avanir 41 biosimilar medicines 41 Patent expiries 41 Lyrica pregabalin 41 Aphthasol R 41 multidose 41 Gilenia 41 Aloxi 41 Congress reauthorizes 41 DPX Survivac 41 Combating Counterfeit Drugs 41 AMPAKINE CX# 41 Inhaled Insulin 41 Stalevo ® 41 ANDA containing 41 Bazedoxifene 41 infant formula contaminant 41 Votrient 41 Avastin bevacizumab 41 VPRIV 41 ATD gel 41 Surfaxin LS 41 IV acetaminophen 41 Dabigatran etexilate 41 OROS R Hydromorphone 41 Preotact R 41 Rosiglitazone 41 Mepact 41 ALTACE 41 SANVAR 41 postmarket studies 41 SFDA approval 41 PrandiMet TM 41 reslizumab 41 motavizumab 41 FFDCA 41 FDAâ € ™ 41 Topiramate tablets 41 Paragraph IV certification 41 Velac 41 Adventrx 41 rosuvastatin calcium 41 vitro dissolution 41 oral antihistamine 41 proposed rulemaking NPRM 41 formulary 41 Biogenerics 41 Mylan Receives Approval 41 clinical trials 41 SYCREST 41 Stock Repurchase Plan 41 Applicant Guidebook 41 oxaliplatin injection 40 ICH E# 40 submit Biologics License 40 Troxatyl TM 40 pharmacovigilance 40 KV Pharma 40 Wyeth Progenics 40 divalproex ER 40 LLY 40 Xyrem ® 40 seroquel quetiapine 40 nasal bepotastine 40 Urocidin TM 40 Galvus vildagliptin 40 highly purified pasteurized 40 Suprax 40 generic omeprazole 40 ANDAs abbreviated 40 Marketing Authorization Applications 40 TRADJENTA 40 SOLODYN R 40 Phospha E R 40 Medicare Modernization Act 40 OsmoPrep 40 Salix Pharma 40 PLAVIX 40 Visicol 40 pramlintide 40 laropiprant 40 Lipofen 40 PTH1 40 PLK1 SNALP 40 Bionutrics 40 Daytrana ® 40 diarrhea predominant irritable 40 Priligy 40 MEVACOR 40 OTC ZEGERID 40 Synerx Pharma 40 Teysuno 40 USFDA approval 40 GLUMETZA ® 40 Lovaza TM 40 Cesamet 40 Rimonabant 40 MEPACT 40 #mg #mg #mg #mg [002] 40 Pazopanib 40 levetiracetam Keppra 40 generic gabapentin 40 Linjeta ™ 40 Levothyroxine 40 GRAS notification 40 Metabolic Drugs 40 Zyprexa olanzapine 40 Nascobal Nasal Spray 40 DNDN 40 pantoprazole sodium 40 CAPHOSOL 40 postmarketing 40 Partnering Guide 40 AVANDIA 40 Orphan Drug designation 40 END FOOTNOTE 40 CAMR 40 Uplyso 40 Hexvix 40 Raptiva R 40 Xolegel 40 VitiGam 40 bullish trending upward 40 Acurox r 40 PrandiMet 40 calcitonin 40 LOCs unless 40 Oxytrol 40 Oracea R 40 VCRT 40 AstraZeneca Toprol 40 Generic Versions 40 Carbidopa Levodopa 40 Ciclesonide 40 Estorra 40 #mg capsules [002] 40 Bupropion 40 UCB Keppra 40 Seroquel XR 40 Lialda 40 FIFRA 40 Factive 40 sitaxsentan sodium 40 Amylin Byetta 40 TPNA 40 miconazole MBT 40 NBIX 40 Symlin 40 Terbinafine 40 LibiGel ® 40 pharmacoeconomic 40 HepeX B 40 Increlex 40 CryoSeal FS System 40 Mycophenolate mofetil 40 Esbriet ® 40 Periostat 40 Novartis AG Galvus 40 OMP designation 40 subcutaneous formulation 40 Joel Sendek 40 Marketing Authorizations 40 conjugated estrogens 40 Vivus Qnexa 40 Ranexa 40 #L Sterilizer 40 candidate deforolimus 40 Praecis 40 Administration TGA 40 solifenacin succinate 40 Cangrelor 40 IPXL 40 SILENOR ™ 40 Glatiramer Acetate 40 Registration Evaluation Authorization 40 asenapine 40 Ralivia ER 40 ReFacto 40 Vpriv 40 MoxDuo 40 USPTO 40 Intellipharmaceutics 40 anti arrhythmic 40 nitrofurantoin 40 Maleate 40 rulemaking 40 BLA resubmission 40 ASONEP 40 Angiomax bivalirudin