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(Click for frequent words.) 56 approvability 54 approvable letter 52 Nebido 51 resubmission 50 Orathecin 50 alogliptin 50 approvable letters 50 Afrezza 50 FDA approvable letter 49 Amyvid 49 REMOXY NDA 49 FDA 48 generic Copaxone 48 QNEXA 48 ezogabine 48 Velac 48 Biologics Licensing 48 MK #B 48 Complete Response 48 Kynapid 47 Priority Review 47 MyVax 47 SILENOR 47 sNDA 47 Bydureon 47 alvimopan 47 Fampyra 47 Afresa 47 PDUFA date 47 Sparlon 47 Preos 47 European Medicines Evaluation 47 Xinlay 46 Marketing Authorisation Application 46 lorcaserin NDA 46 Telavancin 46 Ampligen 46 Cladribine 46 Entereg 46 SPARLON 46 injectable formulations 46 Intermezzo ® NDA 46 NDA submission 46 Approvable 46 Certriad 46 Premarket Approval 46 Complete Response Letter 46 FDA Oncologic Drugs 46 Zolpimist 46 Sanctura XR 46 Arxxant 46 Riluzole 46 guanfacine extended release 46 Nabi HB Intravenous 45 Metformin GR 45 Indiplon 45 Bifeprunox 45 PDUFA 45 CHMP recommendation 45 Horizant 45 Orphan Status 45 Rasilez HCT 45 CIP TRAMADOL ER 45 Onrigin 45 Byetta LAR 45 Subpart H 45 Complete Response letter 45 ONGLYZA ™ 45 Torisel 45 liprotamase 45 Focalin XR 45 Anti Infective Drugs 45 Krystexxa 45 Ofirmev 45 anti arrhythmic 45 SEROQUEL XR 45 Frova ® 45 FDA Advisory Panel 45 Ranexa 44 Zenpep 44 sBLA 44 Marketing Authorization Application 44 Accelerated Approval 44 Tredaptive 44 investigational 44 Gilenia 44 Clolar 44 PRISTIQ 44 Civacir 44 PIX# trial 44 Exalgo 44 generic Lovenox 44 BRILINTA 44 Promacta 44 Voraxaze 44 FDA Approvable Letter 44 Somatuline R Autogel R 44 Stavzor 44 balsalazide tablet 44 Emezine 44 Zalbin 44 bifeprunox 44 BLA filing 44 CHMP 44 Formal Dispute Resolution 44 Seroquel XR 44 daily Glumetza TM 44 Linjeta TM 44 Pulminiq 44 Not Approvable 44 Vilazodone 43 Nuedexta 43 HCl capsules 43 Rasagiline 43 PDUFA Prescription Drug 43 FDA Complete Response 43 Joulferon 43 Cerepro 43 Barr ANDA 43 Sycrest 43 Doribax 43 Xyotax 43 Pirfenidone 43 Emend 43 Spiriva HandiHaler 43 PROVIGIL 43 Fablyn 43 DORIBAX 43 Toctino ® alitretinoin 43 PhosLo 43 levetiracetam Keppra 43 Trobalt 43 motavizumab 43 Pristiq 43 Metabolic Drugs Advisory 43 Aplenzin 43 Fast Track designations 43 GRALISE 43 Firazyr 43 Alimta pemetrexed 43 Inamed silicone implants 43 Ropinirole 43 faropenem 43 Keppra ® levetiracetam 43 Avastin bevacizumab 43 Junovan 43 Frova 43 indiplon capsules 43 sNDA submission 43 Vidaza azacitidine 43 Expedited Review 43 Oncologic Drugs Advisory 43 supplemental Biologics License Application 43 casopitant 43 Lorqess 43 Azathioprine 43 Marketing Authorization 43 analyst Simos Simeonidis 43 bioequivalence 43 fluvoxamine maleate 43 Frova R 43 Neupro 43 BLA submission 43 Cellegesic 43 Entocort 43 midodrine 42 FDA Psychopharmacologic Drugs 42 CDER 42 EMBEDA 42 Kiacta 42 Alogliptin 42 SURFAXIN 42 Premarket Approval Application 42 vitro dissolution 42 Vimovo 42 Zensana 42 Complete Response Letter CRL 42 Onsolis 42 self affirmed GRAS 42 Gralise 42 Drug Administration FDA 42 Xyrem ® 42 Trexima 42 Silenor NDA 42 Spiriva Handihaler 42 Marketing Authorisation 42 Treximet 42 Galvus 42 Febuxostat 42 Novartis Galvus 42 cladribine tablets 42 Research CDER 42 Adcirca 42 Biologics License Application BLA 42 bazedoxifene 42 Cancidas 42 Genzyme Myozyme 42 FDA Endocrinologic 42 UCB Keppra 42 dalbavancin 42 Lumizyme 42 ETHEX 42 Medicinal Products EMEA 42 Tyvaso 42 Marketing Authorization Application MAA 42 Potiga 42 ULTRASE 42 Icatibant 41 Orapred ODT 41 Corlux 41 Prexige 41 Bepreve 41 Biologic License Application 41 ACUROX ® 41 Contrave NDA 41 NDA resubmission 41 ONSOLIS 41 Ramelteon 41 Anchen 41 Augment Bone Graft 41 efficacious 41 ZEGERID Chewable Tablets 41 Marketing Authorisation Application MAA 41 Resubmission 41 Saphris 41 Kombiglyze XR 41 Risperidone Oral Solution 41 non selective NSAIDs 41 supplemental biologics 41 Tekturna HCT 41 Drug Application 41 Eli Lilly Zyprexa 41 Relistor 41 Velcade bortezomib 41 pediatric exclusivity 41 blood thinner prasugrel 41 Act PDUFA date 41 Fusilev 41 Psychopharmacologic Drugs Advisory 41 generic biologic 41 Morphine Sulfate 41 Centralized Procedure 41 FDA reviewers 41 Replagal 41 CONBRIZA 41 MAA submission 41 Zyflo CR 41 Anidulafungin 41 Biologic License Application BLA 41 Application BLA 41 Xifaxan 41 Invega 41 Pixuvri 41 Rilutek 41 Ixempra 41 metoprolol succinate 41 OLEPTRO 41 Egrifta 41 Factive 41 REMS 41 Contrave 41 IND Investigational New 41 Cubicin 41 Certican 41 Kaletra tablet 40 ixabepilone 40 Linjeta 40 Zelrix 40 T Pred 40 Asmanex 40 ARCOXIA 40 Thyrogen 40 Tasigna nilotinib 40 Xarelto 40 Aveed 40 capsule formulation 40 Exanta 40 AquaBounty submitted 40 Uloric 40 AVI ESPRIT technology 40 Paragraph IV Notice 40 Ticagrelor 40 Eli Lilly Cymbalta 40 Zavesca 40 Vimpat R 40 Drug Administration 40 Paragraph IV 40 Drug Administration Oncologic Drugs 40 successfully commercialize Iluvien 40 Pulmonary Allergy Drugs 40 Act PDUFA 40 ENRICH trial 40 CHMP opinion 40 Folotyn 40 heterozygous FH 40 VIAject 40 Oral BDP 40 Retacrit 40 LibiGel ® 40 AstraZeneca Symbicort 40 Orexigen Contrave 40 Enjuvia 40 APF# NDA 40 Citizen Petition 40 NOXAFIL 40 FOSAMAX PLUS D 40 Metformin Hydrochloride 40 Irinotecan Hydrochloride Injection 40 Vivus Qnexa 40 ANDA submission 40 F.D.A. 40 Xifaxan rifaximin 40 Linjeta ™ 40 Approvable letter 40 Amylin Byetta 40 HepaGam B 40 darbepoetin alfa Aranesp 40 gadobutrol 40 aripiprazole Abilify 40 Vibativ 40 Oral Solution 40 Drug Submission 40 anidulafungin 40 Viviant 40 Soriatane 40 PDUFA Date 40 telavancin NDA 39 Inhaled insulin 39 PRECISE Trial 39 SANVAR 39 topical NSAID 39 TachoSil 39 NitroMist TM 39 prGCD 39 Zelapar 39 Premarket Approval PMA 39 improvidently granted 39 painkiller Prexige 39 European Medicines Agency 39 commercialize toremifene 39 Vertex hepatitis C 39 Dacogen injection 39 Esbriet 39 Anchen Pharmaceuticals Inc. 39 alogliptin NDA 39 Xarelto rivaroxaban 39 submit Biologics License 39 ustekinumab 39 FENTORA 39 placebo controlled studies 39 ANDAs 39 GRAS status 39 USFDA approval 39 Generic Version Of 39 Omapro 39 Novartis Prexige 39 Cethromycin 39 Rhucin ® 39 Mitigation Strategy REMS 39 postapproval 39 Symlin 39 Novartis AG Galvus 39 granisetron hydrochloride 39 Dificid 39 Wellbutrin bupropion 39 Aegerion 39 Vandetanib 39 successfully commercialize Silenor 39 LibiGel NDA 39 Dostinex 39 sNDAs 39 Actemra 39 Market Approval PMA 39 spokesman Tony Plohoros 39 PROTONIX 39 Mepact 39 ZEGERID Capsules 39 Zarnestra 39 liver resection surgeries 39 FDA Accepts 39 EMBEDA ™ 39 Foradil 39 Omnitrope 39 Foradil Aerolizer 39 TWYNSTA ® 39 MVLWB 39 revoke Menaflex approval 39 Noxafil 39 Muraglitazar 39 Velaglucerase Alfa 39 Galida 39 Dexilant 39 Mylotarg 39 Elan Tysabri 39 Drug Administration FDA Oncologic 39 authority Gurian Sherman 38 Protopic 38 contraindicate 38 Qualaquin 38 NerPharMa 38 Cylert 38 Galson 38 Biologics License Application 38 Glaxo Serevent 38 Vitrasert R 38 Tekturna HCT ® 38 AZILECT R 38 ANDA applicant 38 pantoprazole sodium 38 postmarketing surveillance 38 Amphastar 38 Celgene Revlimid 38 FDA Anti Infective 38 Prexige lumiracoxib 38 Plenaxis TM 38 assigned PDUFA 38 Oncology Drug 38 ImClone Erbitux 38 injectable gel 38 Cenestin 38 Reclast Aclasta 38 Swissmedic 38 biogeneric drugs 38 Cefazolin 38 Liprotamase 38 Drug Administration USFDA 38 Aloxi Injection 38 immunosuppressant therapies 38 Drugs Advisory 38 Humira adalimumab 38 MEVACOR 38 NitroMist 38 FDAs 38 Myfortic 38 ZURICH AFX Novartis AG 38 Salix Pharma 38 Orexigen 38 NEBIDO 38 Altabax 38 Adventrx 38 #mg #mg #mg #mg [002] 38 Zemplar 38 ANDAs abbreviated 38 novel bactericidal 38 Endeavor Drug Eluting 38 Zimulti 38 application sNDA 38 Sporanox 38 Tygacil 38 Dendreon Provenge 38 User Fee Act 38 BiDil XR 38 Daliresp 38 prefilled syringe 38 Hycamtin 38 Estratest 38 Appreciable downside risks 38 Supplemental Biologics License Application 38 Fosrenol 38 DAS# remission 38 enoxaparin sodium 38 PMA submission 38 EGRIFTA TM 38 Galvus vildagliptin 38 Removab 38 Biophan patent 38 Telzir 38 Metozolv ODT 38 Zytiga 38 Lilly Cymbalta 38 Acthar Gel 38 Rapaflo 38 propoxyphene containing 38 Encysive Pharmaceuticals Nasdaq ENCY 37 Invega Sustenna 37 Evicel 37 GRAS affirmation 37 Sunovion 37 ANDA abbreviated 37 Pfizer Geodon 37 OraTest 37 Acomplia rimonabant 37 mesylate tablets approved 37 USFDA 37 Surfaxin lucinactant 37 MDUFMA 37 Ozurdex 37 Acurox 37 SPIRIVA HandiHaler 37 Topiramate tablets 37 Lilly Evista 37 Marketing Authorization Applications 37 PMA Supplement 37 TNF blocker 37 ANDA filings 37 pulls Darvon painkiller 37 DDMAC 37 generic Allegra 37 sirtuin modulators 37 Ariva BDL 37 Novartis AG Foradil 37 pill Contrave 37 Glycopyrrolate 37 COX 2s 37 painkiller Arcoxia 37 FDA Antiviral Drugs 37 Serevent 37 QbD 37 Tequin 37 inspectional observations 37 Isaac Toussie lawyer 37 DCGI 37 Augment ™ Bone Graft 37 CDRH 37 Victoza 37 Novo Nordisk Victoza 37 Fortical R 37 OHRP 37 Sanofi Aventis Acomplia 37 Receives Approvable Letter 37 Symbyax 37 renal toxicity 37 Heparin Sodium 37 Synerx 37 Fortesta 37 Fortigel 37 Cintredekin besudotox 37 Celebrex celecoxib 37 LUVOX CR 37 Board DSMB 37 UCB Cimzia 37 Zyflo 37 Zegerid OTC 37 Moxatag 37 Pfizer Sutent 37 teratogenicity 37 postmarket surveillance 37 Submits Investigational 37 Bioequivalence 37 Dr. Pazdur 37 clinical trials 37 AdreView 37 Lilly Zyprexa 37 Administration TGA 37 Arranon 37 antidepressant trazodone 37 hypersensitivity allergic reactions 37 highly purified pasteurized 37 CDER FDA 37 Tysabri natalizumab 37 buccal tablets 37 Evista 37 Sanofi Acomplia 37 en banc rehearing 36 sBLA filings 36 Patanase 36 Montelukast 36 Optimark 36 Praecis 36 Provenge prostate cancer 36 clinically meaningful endpoint 36 Botox Botox Cosmetic 36 granted Ortec 36 Accolate 36 reapproval 36 FDA Pulmonary Allergy 36 Lipofen 36 Pfizer Lyrica 36 Biegelsen 36 orphan medicinal 36 varenicline tartrate 36 Paxil paroxetine 36 clopidogrel bisulfate 36 spokeswoman Naomi Aoki 36 EXALGO 36 Prescription Drug User Fee 36 Bazedoxifene 36 EvaMist NDA submission 36 Fosphenytoin 36 Medicinal Products 36 NMEs 36 Gamunex C 36 Biosante 36 Diastat 36 METOZOLV ODT 36 administrable 36 Triage Stroke Panel 36 postmarketing studies 36 AstraZeneca Iressa 36 Arzerra 36 Afinitor everolimus 36 AMAG 36 gave Makena orphan 36 Devices Advisory Panel 36 biosimilar 36 Receives Tentative FDA 36 Actavis Totowa 36 OROS R Hydromorphone 36 OTC Zegerid 36 Coreg CR 36 Advair Diskus 36 Pre IND 36 ex parte reexamination 36 Bergenstal 36 Oxytrol 36 ACNFP 36 milligram dosage 36 submitted Biologics License 36 Von Eschenbach 36 nitrofurantoin 36 CERVARIX R 36 Intelence 36 Biogen Elan 36 Tykerb 36 developed preclinically 36 Vpriv 36 showing Darvon interferes 36 carbinoxamine 36 OvaDx 36 FACTIVE R gemifloxacin 36 spokeswoman Lenore Gelb 36 Bristol Myers Squibb Abilify 36 submitted Marketing Authorization 36 McNeil Pediatrics 36 approve telavancin 36 Hexvix 36 Synthon 36 GRAS notification 36 Aptivus 36 Boxed Warning 36 BioDelivery Sciences 36 Asclera 36 Vitaros 36 Cangrelor 36 Effient 36 Colazal 36 premarket notification 36 Injectafer 36 biogeneric 36 spokesman Jeffrey Leebaw 36 Exelbine NDA 36 Genetic Therapies Directorate 36 Stonewall BDL 36 unblind 36 PMPRB 36 Bridion 36 FDA GRAS 36 rehearing 36 postmarket 35 Medtronic stent 35 Feraheme ® 35 Generic Version 35 Enteryx 35 Darvocet Darvon 35 Cinryze 35 Stelara 35 maker Barr Pharmaceuticals 35 IV acetaminophen 35 requiring Asthmatx 35 Biological License Application 35 Fentora 35 Purepac 35 immune suppressing medication 35 Xibrom QD 35 Elidel 35 Natroba 35 Acthar repository corticotropin injection 35 Increlex 35 declaratory ruling 35 major traumas Luque 35 Auralgan 35 National Coverage Determination 35 administratively feasible 35 CRp 35 Accelerating apoptosis may 35 Merck Arcoxia 35 silicone gel filled 35 rivaroxaban Xarelto 35 implied volatilities tend 35 Taxus Liberte 35 Medsafe 35 Teflaro 35 Levothyroxine Sodium 35 DYSPORT 35 easypod R 35 rotavirus vaccine Rotarix 35 USPTO 35 vaccine RotaTeq 35 DPP4 inhibitor 35 Latuda 35 Cesamet 35 OMRI 35 HPV vaccine Cervarix 35 Expanded Indication 35 GSK Avandia 35 Skibine 35 cGMPs 35 Xience V stent 35 ADCS CGIC 35 fiscally feasible 35 Avanir 35 Pentacel vaccine 35 Susan Bro 35 Richard Pazdur director 35 fundable 35 Prezista 35 Elestrin TM 35 k Premarket Notification 35 SEASONALE 35 EFSA 35 CUSF application 35 NeutroSpec 35 Encysive 35 Viibryd 35 Generic Drugs OGD 35 eg NDA BLA 35 PDUFA reauthorization 35 clinical trial 35 Ms Ngazana application 35 antibiotic Ketek 35 Zelnorm 35 CIP Fenofibrate 35 NYID 35 Transkaryotic 35 competition Iraheta Desai 35 BLA resubmission 34 Mitigation Strategies REMS 34 FDAâ € ™ 34 EVICEL 34 WIRB 34 liver toxicity 34 ATryn 34 nasal calcitonin product 34 MAP Pharma 34 durable remissions 34 JANUMET 34 Generic Versions 34 Raanan Bloom 34 Mucotrol 34 Auxilium Pharma 34 fexofenadine 34 treats acute lymphoblastic 34 Visicol 34 clinically meaningful improvement 34 Communications DDMAC 34 Inhaled Insulin 34 Roxane Laboratories 34 Amgen Prolia 34 GTC recombinant form 34 Teri Schrettenbrunner Wells Fargo 34 GlaxoSmithKline Plc diabetes 34 Cerezyme Fabrazyme Myozyme Aldurazyme 34 frivolous Mulrain 34 Nonprescription 34 reargument 34 Merck Januvia 34 Susan Cruzan 34 spokesman Doug Petkus 34 PlanCom 34 overthe counter 34 Gynazole 1 34 Ketek 34 Videx EC 34 eCTD format 34 Drug Evaluation 34 Bayer Xarelto 34 Tysabri 34 Dr. Kate Gelperin 34 generic Flonase 34 Scolr 34 MHRA 34 Benlysta 34 Dal Pan 34 Breviary prayer book 34 JECFA 34 Pat El Hinnawy 34 CryoSeal FS System 34 Laura Alvey 34 AFSSAPS 34 Budeprion XL 34 Pfizer Exubera 34 exenatide Byetta 34 Lotronex 34 DNAwithPap TM Test 34 Sotret 34 OsmoPrep 34 initiate Phase IIb 34 Dulera 34 SCSI Optical Transport 34 Digoxin 34 Menaflex device 34 Wellstat 34 Generally Regarded 34 Xiaflex 34 conjugated estrogen 34 psychopharmacologic drugs advisory 34 Prolia TM 34 patriotism Gration 34 Mofcom 34 non waivable 34 Product Characteristics 34 summary judgment de novo 34 Amevive 34 Levemir 34 DrugAdministration 34 Pharmacopeial USP Convention 34 resubmitting 34 rhThrombin 34 Livalo 34 pharmacologically relevant 34 BioDelivery 34 Drug Adminstration 34 FDA Adverse Event 34 Propoxyphene 34 Xanodyne 34 Xgeva 34 AstraZeneca Brilinta 34 Firdapse ™ amifampridine phosphate 34 LDTs 33 Armour Thyroid 33 drug eluting coronary stents 33 Kapidex 33 Warning Letter 33 Nonprescription Drugs 33 oral sodium phosphate 33 SEQR 33 reapprove 33 decongestants expectorants antihistamines 33 WHO prequalification 33 Energy Facility Siting 33 bloodthinner 33 Xolair 33 Research CBER 33 laromustine 33 adequately capitalized 33 HPV vaccine GlaxoSmithKline Cervarix 33 Toprol 33 Submits Supplemental 33 Reimportation 33 adequately collateralized 33 bovine thrombin 33 SFDA approval 33 Propulsid 33 gelcaps 33 AVANDIA 33 reconsideration 33 Combined License Application 33 highly emetogenic chemotherapy 33 FDA Modernization Act 33 somatoform disorder 33 containing propoxyphene 33 AneuRx 33 domperidone 33 DUR ee 33 ASLB 33 Vioxx Celebrex 33 FluLaval 33 commercialize oritavancin 33 Upsher Smith 33 insulin inhaler 33 AIR inhaled insulin 33 Rosiglitazone 33 Qualifications Panel 33 conduct postmarketing 33 Prescribing Information 33 spokeswoman Amanda Eamich 33 Endothelin receptor antagonists 33 estriol 33 Metabolic Drugs 33 Avandia Actos 33 India DCGI 33 Dr. Rafel Rieves 33 Vivus 33 Augment ™ 33 Ampyra 33 GPhA 33 commercialize DAVANAT ® 33 mesylate tablets 33 GMPs 33 acceptable 33 Palatin Technologies 33 Pfizer inhaled insulin 33 equivalent Reglan 33 HSR clearance 33 Cellular Tissue 33 COLAZAL 33 Genentech Raptiva 33 BioMimetic 33 Ranbaxy Paonta Sahib 33 resubmits 33 Loveberg 32 regenerative medicine therapies 32 inhalable 32 WWW browser 32 MelaFind 32 FSANZ 32 DATES Written comments 32 Chief Executive Henri Termeer 32 #k PMA sNDA 32 Drug Administration FDA Endocrinologic 32 COPN 32 anticlotting drug 32 Meloxicam Tablets 32 License Application 32 Douglas Petkus 32 #k Clearance 32 antibiotic Cubicin 32 Invirase 32 Delaying apoptosis may 32 multidose vials 32 Added Piro 32 Barr Laboratories Inc. 32 substitutable 32 Xanodyne Pharmaceuticals 32 temporarily wheezing shortness 32 Biosimilars 32 Lopez Terradas 32 Intrinsa 32 virologic suppression 32 TPSAC 32 AdhTAP 32 USDA FSIS 32 presumptively valid 32 nonresponsive 32 spokesman Phil Budahn 32 diagnosed chronic myeloid 32 Rotarix ® 32 infant formula contaminant 32 FDA Approval 32 Mylan ANDA 32 mg usa 32 reactions somnolence dizziness 32 lender consents 32 compliant 32 Kweder 32 LensAR Laser System 32 creating cheaper passcard 32 carotid stent 32 Raja Azmi submitted 32 approvals 32 Arena Pharmaceuticals ARNA 32 postmarket studies 32 achieve sustained virologic 32 Amgen Nplate 32 Prosecutor Vera Pashkovskaya 32 Sensitivity analyzes 32 eMDR 32 Joseph Famulare deputy 32 combine recombinant protein 32 ANVISA 32 ENLIGHT 32 Priligy 32 resubmit 32 y Ambiente SERNA Honduras 32 Xience 32 ICH E# 32 township Zoning Hearing 32 resolvable 32 Cleviprex 32 Atryn 32 Marketing Approval PMA 32 von Eschenbach 32 Fluarix vaccine 32 resubmitted 32 economically feasible 32 legally binding Perez Roque 32 ISMP 32 unfavorable cytogenetics 32 MoviPrep 32 agendized item 32 Dossier IMPD 32 ARIXTRA R 32 SWHCS 32 biogenerics 32 postmarketing 32 Abstral 32 FLUVIRIN vaccine 32 spokesman Bo Piela 31 Drug Administration Amendments 31 ICH guidelines 31 ulipristal acetate 31 spokeswoman Wendi Kopsick 31 levothyroxine sodium 31 Recothrom 31 replead 31 Amgen Aranesp 31 application 31 develop GED aPC 31 initiate rulemaking 31 FDAAA 31 Iressa gefitinib 31 spokesman Alexander Klauser 31 OTC Mevacor 31 synDNA TM 31 KV Pharma 31 achievable 31 recombinant thrombin 31 Tom Baranowski pediatrics 31 Humenza