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(Click for frequent words.) 74 Act PDUFA date 71 PDUFA 67 Act PDUFA 67 FDA approvable letter 65 Prescription Drug User Fee 63 PDUFA Prescription Drug 63 MAA submission 63 BLA filing 62 Biologics License Application BLA 61 alogliptin 61 Exalgo 61 Complete Response letter 61 IND submission 60 FDA Approvable Letter 60 NDA submission 60 ZEGERID Chewable Tablets 59 sNDA 59 Orathecin 59 Biologics License Application 59 BLA submission 59 sBLA 59 alvimopan 58 Biologics Licensing 58 Zelrix 58 Nebido 58 Complete Response 58 ISO Vorin TM 58 APF# NDA 58 Marketing Authorization Application 58 CIP TRAMADOL ER 58 NEBIDO 58 Voraxaze 58 approvable letters 58 dalbavancin 58 PDUFA Date 58 assigned PDUFA 58 Auxilium Pharma 58 Complete Response Letter 58 sNDA submission 58 Stavzor 58 Complete Response Letter CRL 58 Intermezzo ® NDA 58 Preotact 57 Application BLA 57 Approvable Letter 57 Bicifadine 57 approvable letter 57 lorcaserin NDA 57 Icatibant 57 NDA resubmission 57 FDA Complete Response 57 Civacir 57 Troxatyl 57 JZP 57 SILENOR TM 57 IND Investigational New 57 registrational 57 Afrezza 57 ZEGERID Capsules 57 oral ridaforolimus 57 Fast Track designation 57 approvability 57 BENLYSTA 57 Biologic License Application BLA 56 Hematide ™ peginesatide 56 Oracea 56 mesylate tablets 56 supplemental biologics 56 pediatric exclusivity 56 CHMP recommendation 56 Onsolis 56 User Fee Act 56 Luveniq 56 pralatrexate 56 Zerenex 56 Horizant 56 Somatuline R Autogel R 56 FACTIVE R gemifloxacin 56 Plicera 56 FDA Oncologic Drugs 56 Sanctura XR 56 oxymorphone ER 56 FDA Advisory Panel 56 maribavir 56 application sNDA 56 PREOS 55 tramiprosate ALZHEMED TM 55 Marketing Authorisation Application MAA 55 iloperidone 55 Junovan 55 QNEXA 55 Mr. Bentsur 55 eniluracil 55 Krystexxa 55 Gralise 55 Priority Review 55 HuMax CD4 55 Cladribine Tablets 55 Firazyr 55 PMA submission 55 Oncologic Drugs Advisory 55 Zingo TM 55 Marketing Authorization Application MAA 55 XiDay 55 ONSOLIS 55 Folotyn 55 PROMACTA 55 Increlex TM 55 Zytiga 55 BENLYSTA ® 55 Kynapid 55 MONOVISC 55 ezogabine 55 SILENOR 55 orphan designation 55 Zalbin 55 Biologic License Application 55 METOZOLV ODT 55 Marketing Authorisation 55 BRILINTA 55 octreotide implant 55 TOCOSOL Paclitaxel 55 Promacta 55 Phase Ib study 55 NUVIGIL 55 OMP designation 55 New Drug Application 55 Camvia 55 AeroLEF 55 Gestiva TM 55 Nasdaq OSCI 55 Phase IIb trials 55 Dacogen injection 54 zanolimumab 54 Orexo 54 CRMD# 54 resubmission 54 See BioWorld Today 54 supplemental Biologics License Application 54 NASDAQ AVNR 54 Application MAA 54 generation purine nucleoside 54 ruxolitinib 54 Drug Submission 54 eprodisate Fibrillex TM 54 peginesatide 54 oral methylnaltrexone 54 ponatinib 54 Marketing Authorisation Application 54 Zenvia ™ 54 LidoPAIN SP 54 elotuzumab 54 INCB# [002] 54 NASDAQ BDSI 54 balsalazide tablet 54 RSR# 54 bazedoxifene 54 PhosLo 54 DPX Survivac 54 NASDAQ PGNX 54 MK #B 54 Orexigen Contrave 54 sNDA filing 54 Zenpep 54 tiapamil 54 BEMA Granisetron 54 Ventrus 54 Zensana 54 Cellegesic 54 Mozobil 54 Bepreve 54 MAXY alpha 54 Bydureon 54 Premarket Approval Application 54 albinterferon alfa 2b 54 Marqibo 54 Feraheme 54 Ceflatonin 54 Phenoptin 54 Corlux 54 Evoltra TM 54 cycle oral contraceptive 54 MOZOBIL 54 Alnara 54 proprietary transdermal patch 54 Clavis Pharma 54 Orphan Drug Designation 54 Glybera 54 Inc. NASDAQ BPAX 54 SWX BSLN 54 AAG geldanamycin analog 53 methylnaltrexone 53 ATryn R 53 MethyPatch 53 NPSP# 53 Evoltra ® 53 Frova ® 53 vilazodone 53 CHMP 53 corticosteroid dexamethasone 53 Silenor ® doxepin 53 BioDelivery Sciences 53 Allovectin 7 53 Trelstar R 53 ambrisentan 53 zileuton CR 53 Zipsor 53 RIGScan CR 53 Intuniv 53 Evoltra R 53 LymphoStat B TM 53 torezolid phosphate 53 ridaforolimus 53 SURFAXIN 53 Surfaxin lucinactant 53 Flutiform TM 53 GATTEX TM 53 registrational trial 53 Aegerion 53 Somatuline Depot 53 Anti Infective Drugs 53 FDA Endocrinologic 53 Gestiva ™ 53 metoprolol succinate 53 Personalized Immunotherapy 53 nalbuphine ER 53 Zolpimist 53 T Pred 53 Nasdaq OPTR 53 BEMA Buprenorphine 53 CHMP opinion 53 ZENPEP 53 Somatuline Autogel 53 Xibrom QD 53 Octreotide 53 ENTEREG ® 53 Q#IR 53 Kuvan 53 Accelerated Approval 53 Fibrillex TM 53 Oracea TM 53 Emezine 53 Abiraterone acetate 53 Risperidone Oral Solution 53 BDSI 53 Æterna Zentaris 53 L MTP PE 53 FOLOTYN ® 53 Phase 2b trial 53 Sular formulation 53 talactoferrin 53 Plenaxis R 53 Indiplon 53 ANDAs 53 prGCD 53 Mannkind 53 phase IIb 53 naproxen esomeprazole magnesium 53 SILENOR ™ 53 NYSE Amex PTN 53 apaziquone 53 Velac 53 Nasdaq SPPI 53 lintuzumab SGN 53 velaglucerase alfa 53 ANDA filings 53 Adcirca 53 ENZON 53 Archexin 53 mipomersen 53 generic Lipitor 52 Lupuzor 52 clofarabine 52 ANTEGREN 52 L BLP# 52 Rhucin ® 52 Kamada AAT 52 forodesine 52 tafamidis 52 orphan drug 52 Exalgo TM 52 Asentar 52 Guanilib 52 Cinryze TM 52 Aurexis 52 Prestara 52 Flutiform 52 Files Investigational 52 confirmatory Phase III 52 ENRICH trial 52 Vasovist 52 Ophthalmic Drugs Advisory 52 naronapride 52 KRYSTEXXA TM pegloticase 52 Trexima 52 ER oxymorphone hydrochloride 52 AZD# TC 52 NEBIDO R 52 Nasdaq CYCC Nasdaq CYCCP 52 Santhera 52 Benlysta belimumab 52 Cimzia TM 52 bicifadine 52 ATryn ® 52 Pre IND 52 ISTODAX 52 Treanda 52 pegloticase 52 tezampanel 52 baminercept 52 Ketotransdel 52 Iluvien ® 52 Provenge prostate cancer 52 ITAX 52 Amigal 52 XIAFLEX ™ 52 Nuvion 52 indiplon capsules 52 Biological License Application 52 Lumizyme 52 FDA Anti Infective 52 daclizumab 52 ULTRASE 52 Nasdaq EPCT 52 Lodotra 52 Annamycin 52 SinuNase 52 ixabepilone 52 Barr ANDA 52 novel trazodone formulation 52 OROS R Hydromorphone 52 OLEPTRO 52 alogliptin NDA 52 Phase III trials 52 REMOXY NDA 52 Tocosol Paclitaxel 52 Gestiva 52 Cladribine 52 Ruconest 52 Hatch Waxman exclusivity 52 markets HP Acthar 52 VIVITROL ® 52 phase IIb trial 52 Tyvaso 52 relapsed MCL 52 PDE4 inhibitor 52 highly purified pasteurized 52 R sipuleucel T 52 Nasdaq QCOR 52 Oglemilast 52 anidulafungin 52 PIX# trial 52 TELINTRA 52 Sprycel dasatinib 52 pseudobulbar affect PBA 52 crofelemer 52 Evamist TM 52 submitted Biologics License 52 vernakalant oral 52 KIACTA ™ 52 OMAPRO 52 Belimumab 52 omacetaxine mepesuccinate 52 Cinryze ™ 52 Testosterone MDTS ® 52 Clolar 52 LibiGel ® 52 confirmatory Phase 3 52 INDs 52 Qutenza 52 lasofoxifene 52 fluvoxamine maleate 52 Saxagliptin 52 AzaSite Plus 52 Nabi HB Intravenous 52 Telavancin 52 Viramidine 52 ONGLYZA ™ 52 Palatin Technologies Inc. 52 unblinding 52 Entereg 52 Fast Track designations 52 Act PDUFA guidelines 52 gabapentin enacarbil 52 Panzem R 52 MAGE A3 ASCI 52 HZT 52 Treximet 51 ADVEXIN 51 NASDAQ CXSP announced 51 Linjeta 51 Tezampanel 51 Vanda Pharmaceuticals 51 phase IIb clinical 51 Clinical Trials Update 51 Ceflatonin ® 51 Actemra tocilizumab 51 OFIRMEV 51 PLK1 SNALP 51 Omapro 51 Zirgan 51 Soliris TM eculizumab 51 MyVax R 51 Solasia 51 Omigard 51 Febuxostat 51 hoFH 51 Fast Track Status 51 Pennsaid 51 PANVAC VF 51 Tasimelteon 51 Velaglucerase Alfa 51 PROVENGE sipuleucel T 51 Strativa 51 BEMA TM LA 51 Glumetza 51 Advagraf 51 oral taxane 51 SUCCEED trial 51 SCOLR Pharma 51 ZEGERID Powder 51 Ixempra 51 PNP inhibitor 51 AVNR 51 faropenem medoxomil 51 Roche Actemra 51 REPLAGAL 51 GLP1 agonist 51 telavancin NDA 51 CRTX 51 TBC# 51 VALSTAR 51 Arzerra ofatumumab 51 Viviant 51 ZEVALIN ® 51 LibiGel NDA 51 OvaRex ® MAb 51 Panzem R NCD 51 Rhucin 51 Encysive 51 Product Monograph 51 Androxal ® 51 Orphan Drug status 51 ILUVIEN ® 51 midstage trials 51 ALGRX 51 Nuedexta 51 LibiGel 51 Firdapse 51 Dyloject TM 51 Pulmonary Allergy Drugs 51 TSRX 51 IIa trial 51 Keryx Biopharmaceuticals 51 Cellegy 51 VitiGam 51 HoFH 51 ONTAK 51 AERx iDMS 51 Sucampo 51 SPARLON 51 ALLSCHWIL BASEL SWITZERLAND 51 Ambrisentan 51 PROVENGE ® 51 midstage studies 51 Dendreon Provenge 51 MGCD# [001] 51 diabetic neuropathic pain 51 unblind 51 ADVEXIN p# therapy 51 paliperidone palmitate 51 generation PNP inhibitor 51 Ceplene 51 Pivotal Phase 51 NASDAQ SVNT 51 prucalopride 51 Orapred ODT 51 Kiacta 51 autologous cellular immunotherapy 51 DepoMed 51 NASDAQ PCYC 51 incyclinide 51 Alvesco R 51 vinflunine 51 Exelbine 51 motavizumab 51 Luvox CR 51 FavId 51 Joulferon 51 Paragraph IV 51 liprotamase 51 opioid induced bowel dysfunction 51 CDP# 51 Fodosine 51 initiated Phase Ib 51 Targretin capsules 51 POSIDUR TM 51 Inc. NASDAQ AVNR 51 Raptiva R 51 DAVANAT ® 51 GALNS 51 Stalevo 51 Metabolic Drugs Advisory 51 SEASONIQUE 51 Arzerra 51 Xolegel 51 LHRH antagonist 51 FDA Orphan Drug 51 AZILECT R 51 Nasdaq BDSI 51 ISPH 51 Adventrx 51 Preos 51 virus HCV protease inhibitor 51 Avanir 51 DCCR 51 post menopausal osteoporosis 51 subcutaneous formulation 51 injectable formulations 51 Pimavanserin 51 NitroMist TM 51 milnacipran 51 Frova 51 JZP 6 51 Drug Application 51 Inc. NASDAQ ACOR 51 FUSILEV ® 51 lucinactant 51 IRX 2 51 Inflazyme 51 SCHWARZ PHARMA 51 EOquin 51 formerly LymphoStat B 51 TAXUS Element Stent System 51 Nimrat Bagga 51 BiDil XR 51 Centralized Procedure 51 Torisel 51 Orphan Drug designation 51 Silenor NDA 51 Drug Administration FDA 51 submit Biologics License 51 SEASONALE R 51 Soriatane 51 Nasdaq VRTX 51 RSD# oral 51 Keryx Biopharma 51 Opana ER 51 Menerba 51 BEMA TM Fentanyl 51 Replagal 51 BYETTA ® 51 Keppra ® XR 51 PREOS R 51 adecatumumab MT# 51 pixantrone NDA 51 M Enoxaparin 51 REMINYL ® 51 severe hypercholesterolemia 51 oxypurinol 51 oral prodrug 51 Teflaro 51 Premarket Approval PMA 50 Glybera R 50 Oracea ® 50 Entocort 50 Serdaxin 50 Solzira 50 Mipomersen 50 Velcade bortezomib 50 Vernakalant 50 Orphan Drug designations 50 vandetanib 50 Phase IIIb clinical 50 FIRMAGON R 50 MAXY VII 50 Fortical R 50 Syncria 50 OLEPTRO TM 50 Acetavance TM 50 Marketing Authorization 50 DAYTRANA TM 50 mifamurtide 50 vemurafenib 50 Ostarine 50 Inc. Nasdaq SEPR 50 dirucotide 50 alvespimycin 50 SNS# T 50 Vandetanib 50 deforolimus 50 APF# 50 ustekinumab 50 AMR# 50 commercialize oritavancin 50 orphan medicinal product 50 Orthopedic Advisory Panel 50 BrachySil 50 Bronchitol 50 FDA Accepts 50 Somaxon Pharmaceuticals 50 Fast Track Designation 50 Ketotransdel ® 50 NOXAFIL 50 nasal calcitonin product 50 Afresa 50 Toctino ® alitretinoin 50 MyVax 50 Vilazodone 50 Inc. Nasdaq VVUS 50 Cushing Syndrome 50 Drug Applications ANDAs 50 anagrelide hydrochloride 50 Pennsaid R 50 Rhucin R 50 TACI Ig 50 Diamyd ® 50 BAY #-# 50 Tarceva TM 50 Fusilev 50 OMAPRO ™ 50 Esbriet pirfenidone 50 BLAs 50 Cangrelor 50 Surfaxin LS 50 indiplon 50 celgosivir 50 granted Ortec 50 Sulonex 50 successfully commercialize Iluvien 50 HDTV Listings 50 Qutenza TM 50 inhaled formulation 50 Exelbine NDA 50 Neuromed 50 Ferumoxytol 50 Amrix 50 KRN# 50 investigational compound 50 Subpart E 50 selective androgen receptor modulator 50 injectable formulation 50 FDA Dermatologic 50 Phase #/#a trial 50 Resubmission 50 IPXL 50 rALLy trial 50 Vertex Pharma 50 Phase III Clinical Trials 50 ZOLINZA 50 Ceflatonin R 50 Extavia 50 Pixuvri 50 StaphVAX R 50 submitted Marketing Authorization 50 tanespimycin 50 FDA 50 Desmoteplase 50 Glumetza TM 50 LUVOX CR 50 investigational hepatitis B 50 LSE SHP NASDAQ SHPGY 50 Synera 50 oral mesalamine 50 Galida 50 Dyloject 50 NASDAQ NPSP 50 LUCASSIN 50 Vidaza azacitidine 50 ganetespib 50 Phase 1b trial 50 Release Capsules 50 Traficet EN 50 lomitapide 50 DORIBAX 50 TroVax ® 50 blood thinner prasugrel 50 Poniard 50 SUMAVEL DosePro 50 aclidinium 50 Fanapt TM 50 Stimuvax R 50 Moxatag 50 IMGN# 50 candidate epratuzumab 50 cannabinor 50 XIBROM 50 alglucosidase alfa 50 Renvela 50 generic Copaxone 50 arzoxifene 50 postoperative ileus POI 50 vidofludimus 50 AMEX ONI 50 Nasdaq SLXP 50 BENLYSTA TM 50 Stelara 50 ospemifene 50 Itopride 50 Tramadol ER 50 Neurodex 50 Jerini 50 Raptiva ® 50 Aspreva 50 Cloretazine ® 50 Ganite R 50 Contrave NDA 50 satraplatin 50 JOSEPH GALLIVAN Issue 50 miconazole MBT 50 Pegloticase 50 atacicept 50 Nasdaq DVAX 50 cinacalcet HCl 50 NasdaqGM NTEC today 50 Phase IIa trial 50 Pivotal Phase III 50 Veronate 50 Gencaro 50 sNDAs 50 Synvisc ONE 50 AZILECT ® 50 License Application sBLA 50 Acetavance 50 BPAX 50 GLUMETZA ® 50 Auxilium Pharmaceuticals 50 BMN 50 velafermin belinostat 50 Prestara TM 50 NASDAQ IMCL 50 Submits NDA 50 eltrombopag 50 ANDA containing 50 NASDAQ INGN 50 subsidiaries visit http:/www.apricusbio.com 50 Inc. Amex SYI 50 Lamictal ODT 50 Dacogen 50 REBETOL combination therapy 50 Xinlay 50 linaclotide 50 ARCOXIA 50 AMRIX 50 CorMedix 50 Phase III Clinical Trial 50 rhThrombin 50 Brentuximab Vedotin SGN 50 PRISTIQ 50 POZN 50 VIMOVO 50 Receives Fast Track 50 Coreg CR 50 Bioral Amphotericin B 50 CoFactor 50 Transcept Pharmaceuticals 50 DPP4 50 SYCREST 50 BioSante Pharmaceuticals 50 ruboxistaurin 50 Drug Eluting Stent System 50 Amlodipine Besylate Tablets 50 Pliaglis 50 Ceplene TM 50 NovaDel 50 Elagolix 50 Pirfenidone 50 Frova R 50 GRALISE 50 cystinosis patients 50 LEVADEX ™ 50 Keppra XR 50 oncology indications 50 Albugon 49 BLP# Liposome Vaccine 49 NASDAQ SHPGY 49 Eniluracil 49 Contrave 49 cethromycin NDA 49 Silenor ® 49 Lorqess 49 Ketotransdel TM 49 Biogen NASDAQ BIIB 49 PRECISE Trial 49 Oral Suspension #mg 49 DepoDur 49 fostamatinib 49 SinuNase TM 49 NBIX 49 AEG# 49 eprodisate KIACTA TM 49 Lidoderm 49 Proquin 49 AcelRx 49 GLUMETZA 49 OvaRex R 49 ASONEP 49 Exenatide LAR 49 Arthritis Advisory 49 OPAXIO 49 JAK2 inhibitor 49 Lumacan 49 FROVA 49 NASDAQ ISPH announced 49 DYAX 49 Celgene Revlimid 49 Antegren 49 BAL# [002] 49 Orphan Designation 49 SinuNase ™ 49 Zactima 49 vernakalant iv 49 Oleptro 49 RhuDex TM 49 Optimer Pharma 49 ANDA approvals 49 Entereg R 49 Galvus 49 Nasdaq CADX 49 oral fludarabine 49 IMA# 49 Oral Suspension 49 Sancuso 49 oral cladribine 49 Premarket Approval 49 QRxPharma 49 liver resection surgeries 49 Board DSMB 49 testosterone gel LibiGel 49 YONDELIS 49 Ofirmev 49 refractory APL 49 Repros 49 Corautus 49 IAP inhibitors 49 Omigard TM 49 MAb therapy 49 Solorel ® 49 Feraheme ® 49 liposomal formulation 49 Nascobal Nasal Spray 49 Survivin antagonist 49 EOquin TM 49 % uracil topical 49 Focalin XR 49 voreloxin 49 Esbriet ® 49 PTH1 49 SPRYCEL ® 49 OraTest 49 Regeneron Pharma 49 NASDAQ ISTA 49 eliglustat tartrate 49 Rotarix ® 49 Lucanix R 49 DAVANAT R 49 Cephalon NASDAQ CEPH 49 anticancer compound 49 dasatinib Sprycel ® 49 CytoFab 49 CORLUX 49 SANVAR 49 Rhucin ® recombinant 49 sumatriptan injection 49 Alnylam Pharma 49 DPP4 inhibitor 49 dextromethorphan quinidine 49 Hedgehog Pathway Inhibitor 49 AMD# [002] 49 Chemical Entity NCE 49 BROMDAY 49 Ticagrelor 49 NDA Submission 49 WILEX 49 Cimzia 49 quetiapine fumarate 49 TRISENOX R 49 Completes Patient Enrollment 49 TRANSDUR Bupivacaine 49 Increlex 49 IRESSA 49 faropenem 49 severe gastroparesis 49 Allos 49 LibiGel ® testosterone gel 49 XL# SAR# 49 Increlex R 49 Esbriet 49 Certriad 49 European Medicines Evaluation 49 Evoltra 49 Lauren Silvernail 49 Files IND 49 Phase IIb clinical trials 49 Orencia abatacept 49 Mepact 49 Intermezzo R 49 bifeprunox 49 Poniard Pharmaceuticals 49 RANK Ligand inhibitor 49 Initiate Phase 49 patent expiry 49 DR Cysteamine 49 Elestrin TM 49 ONXX 49 Anturol TM 49 Besivance 49 Triolex 49 Augment Bone Graft 49 MNTX 49 submitted supplemental Biologics 49 ketolide antibiotic 49 Cardio Vascu Grow 49 orBec 49 Thyrogen 49 Orazol 49 KERRY EGGERS Issue 49 PrevOnco 49 MoxDuo 49 PEG PAL 49 investigational humanized monoclonal antibody 49 SPRIX ® 49 NAMENDA 49 Viibryd 49 TRISENOX 49 EXALGO 49 Cethromycin 49 KERX 49 Byetta LAR 49 VPRIV 49 Savient Pharmaceuticals 49 Research CBER 49 CINTREDEKIN BESUDOTOX 49 NGSX 49 EPIX Pharmaceuticals 49 By cinelover 49 Orphan Status 49 SCOLR 49 Subpart H 49 ALKS 49 BEXXAR 49 Durect 49 RAPTIVA R 49 ABILIFY ® 49 Polymer Microspheres 49 TSX SHQ 49 asenapine 49 include Phenoptin TM 49 Metformin GR 49 Urocortin 2 49 KRYSTEXXA 49 SAR# [002] 49 CIMZIA r 49 COLAZAL 49 INTUNIV TM 49 sitaxsentan sodium 49 JOULFERON 49 REMOXY R 49 StaphVAX 49 XL# anticancer compounds 49 Nasdaq TSPT 49 Onglyza 49 RELISTOR ® 49 Nexavar sorafenib 49 SUPPRELIN R LA 49 terlipressin 49 Cubist Pharmaceuticals Inc 49 APTIMA HPV assay 49 Syntonix 49 Egrifta 49 generic Lovenox 49 Ultracet R 49 Zenvia TM 49 PrevOnco ™ 49 Satraplatin 49 LAF# 49 Phase IIb trial 49 STELARA TM 49 HuMax EGFr 49 Octreolin 49 Ranexa 49 AEterna Zentaris 49 ACCLAIM II 49 Ocrelizumab 49 IL# PE#QQR 49 Zensana TM 49 ACUROX ® 49 REMS 49 CNTO 49 Genz # 49 Aryplase 49 SciClone Pharmaceuticals Inc. 49 USFDA approval 49 desvenlafaxine 49 candidate REP# 49 octreotide acetate 49 omacetaxine 49 FUSILEV 49 PROVIGIL