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(Click for frequent words.) 84 regulatory approvals 73 regulatory clearances 73 antitrust clearance 70 necessary regulatory approvals 67 approval 67 requisite regulatory approvals 66 approvals 61 stockholder approvals 61 customary regulatory approvals 60 shareholder approvals 59 SFDA approval 58 governmental approvals 57 requisite approvals 57 Pending regulatory approvals 56 applicable regulatory approvals 56 stockholder approval 56 Regulatory Approval 56 FIRB approval 54 Orphan Drug designation 54 regulatory 53 customary closing conditions 53 requisite stockholder 53 Zensana 53 USFDA approval 52 customary closing 52 obtaining regulatory approvals 52 successfully commercialize Iluvien 52 Investigational Device Exemption 52 consents authorizations 52 Biologics License Application 52 Approval 52 regulatory authorizations 51 Orphan Drug Status 51 Flutiform 51 sirtuin modulators 51 orphan designation 51 sumatriptan DosePro 51 DC Bead 50 Vitaros 50 JZP 6 50 PMA submission 50 MethyPatch 50 Fast Track designation 50 promote ceftobiprole 50 OIO approval 50 IND Investigational New 50 Biologic License Application BLA 50 Cellegesic 50 Loramyc 50 unitholder approval 50 blood thinner rivaroxaban 50 definitive agreements 50 CLIA waiver 50 definitive documentation 50 Marketing Authorization 49 MONOVISC 49 Glassia 49 CHMP recommendation 49 Orathecin 49 Guidant stent 49 bilastine 49 Allovectin 7 r 49 Evoltra TM 49 Teflaro 49 Civacir 49 Emezine 49 Fluviral 49 ZALBIN 49 BLA filing 49 Exelbine 49 Visian Toric ICL 49 Marketing Authorization Application 49 lender consents 49 Junovan 48 Marketing Authorization Application MAA 48 BLA submission 48 apaziquone 48 Oryx Pharmaceuticals 48 NESINA 48 Loramyc ™ 48 AnGes 48 Increlex TM 48 Hart Scott Rodino 48 Marketing Authorisation Application 48 Nebido 48 Preotact 48 Nabi HB Intravenous 48 NeoLipid drug 48 Fast Track designations 48 CIP TRAMADOL ER 48 Flutiform TM 48 Pennsaid Plus 48 Urocidin 48 BiDil XR 48 Fortigel 48 Tostrex 48 Omigard 48 CoStar stent 48 Synerx 48 ZURICH AFX Novartis AG 48 HepaGam B R 48 APF# NDA 48 eprodisate KIACTA TM 48 Market Approval PMA 48 Sular formulation 48 Surfaxin lucinactant 48 Orphan Status 48 Mutual Recognition Procedure 48 Symbicort asthma 48 Orphan Drug status 48 HSR clearance 48 SynthRx 48 StaphVAX 48 Phase IIa clinical trials 47 Cobalt Pharmaceuticals 47 transfusional iron overload 47 MAb therapy 47 Clinical Trial Application 47 FDA approvable letter 47 Zevtera 47 IND submission 47 Gestiva TM 47 Vibativ 47 generic atorvastatin 47 Urokinase 47 Centralized Procedure 47 commercialization 47 Uplyso 47 ANDA submission 47 OFIRMEV 47 Glaxo Cervarix 47 PerClot 47 Monovisc 47 cytokine immunomodulator 47 blood thinner prasugrel 47 Vasovist 47 Premarket Approval 47 KIF6 Genotyping Assay 47 Dynepo 47 SURFAXIN 47 FIPB approval 47 Acetavance TM 47 approvable letters 47 liprotamase 47 authority NMa 47 market PolyHeme commercially 47 Orphan Drug Designation 47 Viviant 47 Mepact 47 Biologic License Application 47 SYCREST 47 Shonin approval 47 ThromCat 47 securityholder approval 47 histamine dihydrochloride 47 tivozanib AV 47 BEMA Granisetron 47 Preotact R 47 Approvable letter 47 BEMA Fentanyl 47 Phase III clinical trials 47 CIP Fenofibrate 47 hoFH 46 Zeneus 46 Zenpep 46 received CE Conformite 46 MEPACT 46 Yahoo capitulates 46 Approvable Letter 46 GLASSIA ™ 46 Orphan designation 46 Application BLA 46 disinterested shareholder 46 gepirone ER 46 ATryn ® 46 Allovectin 7 46 CDP# 46 sBLA 46 ruxolitinib 46 IV acetaminophen 46 EGRIFTA TM 46 Nycomed GmbH 46 Rotarix R 46 Voraxaze 46 Renvela 46 Evoltra ® 46 GEM #S 46 Calixa 46 Esbriet 46 Fortesta 46 Allovectin 7 R 46 Solasia 46 NerPharMa 46 HepeX B 46 Evoltra 46 PrevOnco 46 liver resection surgeries 46 Antitrust Improvement 46 dalbavancin 46 New Drug Application 46 rThrombin 46 Plenaxis R 46 ELEVESS 46 FIPB nod 46 NovaDel 46 compound CIP FENOFIBRATE 46 FDA Approvable Letter 46 Regulatory Approvals 46 Kynapid 46 Soliris eculizumab 46 CONBRIZA 46 CLIA certification 46 Marketing Authorisation Application MAA 46 GMP certification 46 Biologics Licensing 46 pill Galvus 46 Application MAA 46 Lupuzor 46 midstage clinical trials 46 TaiGen 46 Fodosine 46 JOULFERON 46 Promus Element stent 46 crolibulin TM 46 Premarket Approval Application 46 candidate Ramoplanin 46 Generx TM 46 Fast Track Designation 46 SNY SAN.FR 46 IONSYS 46 SEBIVO 46 Rasilez HCT 46 Replagal 46 sNDAs 46 ZEGERID Chewable Tablets 46 Preos 46 dirucotide 46 Rapinyl 46 repopulate CNS 46 Rescula 46 TAXUS Element Stent System 46 Zalbin 46 Sepracor insomnia 46 EGRIFTA ™ 46 ZEFTERA TM Zevtera TM 46 vinorelbine emulsion 46 PTCRB certification 46 brentuximab 45 cervical cancer vaccine Cervarix 45 Metricath Gemini 45 HSR Act 45 Soliris TM eculizumab 45 Cladribine 45 alogliptin NDA 45 commercialize 45 Eliquis 45 KIACTA TM 45 Biological License Application 45 Taxus Liberte 45 Vitaros ® 45 Fanapt ™ 45 Linjeta TM 45 Enjuvia 45 Trizytek 45 Eligard 45 Ofirmev 45 Cellegy 45 ORTHOVISC mini 45 NitroMed BiDil 45 Cerepro 45 FIRAZYR 45 VANTAS 45 definitive agreement 45 Flutiform ™ 45 generic Copaxone 45 Loramyc TM 45 alogliptin 45 CryoSeal FS System 45 AVINZA ® 45 Brilique 45 Levoleucovorin 45 ColorectAlert TM 45 taliglucerase alfa 45 OMAPRO ™ 45 k clearance 45 CytoFab 45 IV APAP 45 Valtropin 45 Troxatyl TM 45 Drug Submission 45 OLEPTRO 45 intravenous acetaminophen 45 Vitaros R 45 No Objection Letter 45 Gentamicin Surgical Implant 45 Metabasis stockholders 45 Cutanea 45 Solzira 45 Tramadol ER 45 Zensana TM 45 Certriad 45 PREOS R 45 Marketing Authorisation 45 Afresa 45 CryoSeal 45 Omapro 45 PentaLyte R 45 Hanlong transaction 45 Somaxon ability 45 GRAS notification 45 telavancin NDA 45 Humanitarian Device Exemption 45 Orphan Designation 45 Trobalt 45 rapid prototyping patents 45 Merial Intervet 45 successfully commercialize Silenor 45 thetransaction 45 Antegren 45 Orphan Drug designations 45 Symphony tCGM System 45 GLP toxicology studies 45 faropenem 45 midstage studies 45 OMP designation 45 Ascend Therapeutics 45 Erbitux ImClone 45 oral taxane 45 lorcaserin NDA 45 Mozobil 45 Zingo TM 45 Movectro 45 balsalazide tablet 45 SILENOR 45 Kalbitor 45 orally bioavailable compound 45 generic Ovcon 45 clinical trials 45 Somatuline R Autogel R 45 ZEGERID Capsules 45 Kyowa Kirin 45 Medigen 45 Hematide ™ peginesatide 45 Dyloject TM 45 Aphthasol R 45 self affirmed GRAS 45 Velac 45 Medicis Inamed 44 Gattex 44 Entereg TM 44 Contrave NDA 44 Adcirca 44 Cintredekin Besudotox 44 Invicorp R 44 Cutanea Life Sciences 44 Ovation Pharmaceuticals Inc. 44 Patanase 44 supplemental Biologics License Application 44 Rhucin ® 44 Estorra 44 Adventrx 44 DPX Survivac 44 Multiferon R 44 STEDESA 44 Kwang Dong 44 Mycograb 44 AFSSAPS 44 Multiferon 44 Campto 44 CE Marking 44 Japanese Encephalitis Vaccine 44 OvaRex R 44 Bioral Amphotericin B 44 KIACTA ™ 44 AnorMED expectation 44 Fanapt TM iloperidone 44 Mago ® 44 Frova ® 44 Promacta 44 Alimta pemetrexed 44 Shire BioChem Inc. 44 Amlodipine Besylate Tablets 44 Sigma Tau Pharmaceuticals 44 ANDA abbreviated 44 generic Lovenox 44 SILENOR ™ 44 #L Sterilizer 44 Surfaxin LS 44 Synerx Pharma 44 TOCOSOL Camptothecin 44 acquisition 44 CIMZIA r 44 Stavzor 44 XIAPEX 44 Antitrust Improvements Act 44 DRAXIS 44 please visit www.innercool.com 44 Vertex hepatitis C 44 GTC recombinant human 44 Joulferon 44 QFII license 44 Stedesa 44 Biopartners 44 Transkaryotic Therapies TKTX 44 Novartis Galvus 44 Brinavess 44 Eligard R 44 Pennsaid R 44 Submits Response 44 crinobulin 44 tetrabenazine 44 Bronchitol 44 BioSTAR ® 44 Vertex Pharma 44 mifamurtide 44 Exelbine NDA 44 BugOil R 44 viii inability 44 NEBIDO 44 SUMAVEL 44 Vantas 44 CompAir acquisition 44 oral fludarabine 44 Marketing Authorizations 44 aerosolized AAT 44 authorizations 44 Wyeth Torisel 44 Vimovo 44 Pruvel 44 Trubion stockholders 44 Elaprase 44 Somatuline Autogel 44 premerger notification 44 drug ISA# 44 Ipsen SA 44 CEFF financings subject 44 ambrisentan 44 Istodax 44 StaphVAX R 44 intravenous AAT 44 Travelers Diarrhea vaccine 44 REMOXY NDA 44 Junovan TM 44 MyVax 44 pediatric exclusivity 44 Fast Track Status 44 orphan drug 44 Orapred ODT 44 AMITIZA lubiprostone 44 SILENOR TM 44 breast cancer pill Tykerb 44 NDA submission 44 Onco TCS 44 approvable letter 44 Exelon Patch 44 Rheoscience 44 GEM #S ® 44 ANDA filings 44 Sabex Holdings Ltd. 44 transgenically produced product 44 daily bactericidal antibiotic 44 Rhucin R 44 Zytiga 44 PureGraft 44 Shire PLC SHP.LN 44 Icatibant 44 Gestiva 44 TRISENOX ® 44 Promus Element 44 sanofi 44 Periostat 44 rolapitant 44 MAA submission 44 FACTIVE R gemifloxacin 44 Bonefos 44 Investigational Medicinal Product 44 Oncosphere 44 Shigamabs 44 markets HP Acthar 44 Xenazine ® 43 Argatroban 43 Corlux 43 Risperidone Oral Solution 43 Rectogesic 43 gabapentin enacarbil 43 naronapride 43 platforms GVAX 43 HepaGam B 43 Reloxin 43 orBec R 43 Somatuline Depot 43 IND CTA 43 securityholder approvals 43 Exalgo 43 hyperimmune products 43 registrational studies 43 rhThrombin 43 Pulsys 43 Retacrit 43 Shareholder Approval 43 Swiss drugmaker Nycomed 43 Biologics License Application BLA 43 Eligard ® 43 oral methylnaltrexone 43 Hedrin 43 Resolor 43 ENRICH trial 43 Estrasorb 43 Nycomed 43 Human Genetic Therapies 43 AzaSite Plus 43 requisite consents 43 Ixempra 43 Eloxatin ® 43 authorization 43 Metformin GR 43 clearance eg probenecid 43 Paragraph IV certifications 43 Bellus Health 43 Nabi HB R 43 Insegia 43 generic Lipitor 43 Alnara 43 Saforis 43 LOPROX R 43 RAPTIVA R 43 Shin Poong 43 supplemental biologics 43 iChem VELOCITY 43 Drug Administration USFDA 43 sodium oxybate JZP 43 Marketing Authorization Applications 43 zileuton CR 43 Oglemilast 43 Submits Investigational 43 Sebivo 43 Asentar TM 43 Transamerica reinsurance 43 severe hypercholesterolemia 43 LSE PFZ 43 cethromycin NDA 43 Iluvien ® 43 QAB# indacaterol 43 private placement 43 Oral lyn 43 Ablation Frontiers 43 Egrifta 43 pralatrexate 43 TolerRx 43 ComfortScan system 43 daily Glumetza TM 43 EDQM 43 Investigational Device Exemption IDE 43 Lexiscan TM 43 phase IIb trial 43 BrachySil 43 Prednisporin TM 43 Cefprozil tablets 43 ZEGERID Powder 43 LibiGel NDA 43 biogeneric 43 Neuromed 43 Luitpold 43 Davanat 43 Conditional Approval 43 OvaRex ® MAb 43 ELIQUIS 43 PentaStaph 43 TP# CETi 1 43 Lumacan 43 IND enabling 43 T Pred 43 Lumera stockholders 43 BiDil XR drug 43 Vaccinogen 43 Opana ER 43 vernakalant iv 43 antitrust regulators 43 Alvesco R 43 Alnylam RNAi 43 MOZOBIL 43 Ceplene TM 43 KRYSTEXXA 43 satisfactory due diligence 43 BioDelivery 43 Harrah's Caesars merger 43 refusal ROFR 43 biosurgical 43 successfully commercialized 43 GCF certification 43 GP Pharm 43 TSX PLB leading 43 nephropathic cystinosis 43 Novartis Gilenia 43 European Marketing Authorizations 43 cintredekin besudotox 43 PROMUS Element Stent System 43 CRINONE ® 43 Firazyr ® 43 sumatriptan injection 43 CenturyLink Qwest merger 43 generic Valtrex 43 REPEL CV 43 FluBlok 43 Impax ANDA 43 Amlodipine Besylate 43 Phase IIa trials 43 MEZAVANT 43 FDA Approval 43 Sumavel DosePro 43 Impavido R 43 Virium 43 Pantarhei 43 Alvesco 43 LidoPAIN SP 43 Loramyc R 43 Medidur FA 43 Lero Gold 43 Vectibix panitumumab 43 EGRIFTA 43 BioSTAR R 43 BioOne Corporation 43 divestiture 43 Proposed Qualifying Transaction 43 LEP ETU 43 vaccine Cervarix 43 commercialize telaprevir 43 USFDA nod 43 WILEX 43 commercialized DURECT 43 Nellix technology 43 Prodarsan R 43 TQT study 43 voclosporin 43 Taiho Pharmaceutical 43 UCB Cimzia 43 5 lipoxygenase inhibitor 43 confirmatory Phase III 43 Premarket Approval PMA 43 Announces Tentative Approval 43 Reclast Aclasta 43 Tyvaso 43 PDTI 43 Firazyr 43 BENLYSTA 43 Roche Chugai 43 Mylan ANDA 43 heterozygous FH 43 commercialize DAVANAT ® 43 Stimuvax R 43 Abstral 43 Consummation 42 Prokhorov Onexim 42 Tetrabenazine 42 CureTech 42 LUCASSIN 42 Relistor 42 DAYTRANA TM 42 KRYSTEXXA TM pegloticase 42 KRYSTEXXA ™ 42 blood clot preventer 42 anidulafungin 42 Doribax 42 sterile lidocaine patch 42 intravenous formulations 42 ANDA filer 42 inhaled AAT 42 Oracea ® 42 Certican 42 Ketotransdel 42 Onsolis 42 Dermylex 42 render PolyHeme obsolete 42 Clevudine 42 Zavesca r 42 JHP Pharmaceuticals LLC 42 Omigard TM 42 Moxatag 42 HuMax TAC 42 Irinotecan Hydrochloride Injection 42 Rhucin 42 Dexo 42 Decentralized Procedure 42 Ventrus 42 SonoPrep device 42 Tekamlo 42 exemptive relief 42 Seikagaku 42 Firdapse 42 Barr ANDA 42 Ampligen r 42 highly purified pasteurized 42 Ceplene histamine dihydrochloride 42 zileuton IV 42 Cannasat 42 Power3 patent 42 Topiramate tablets 42 mutually acceptable definitive 42 Oleptro 42 Shigamabs R 42 Thalomid R 42 RAPIACTA ® 42 Surfaxin 42 Kirin Pharma 42 vinflunine 42 EpiCept NP 1 42 Efient 42 Dulera 42 alvimopan 42 RxKinetix 42 P#X# antagonist 42 enoxaparin sodium injection 42 ACEON R perindopril erbumine 42 Recothrom 42 initiate Phase IIb 42 DYNACIN R Tablets 42 sNDA filing 42 PROMUS Element 42 BioGlue ® 42 OLpur TM H2H 42 transaction 42 lucinactant 42 FCC PTCRB 42 Zerenex 42 BioDelivery Sciences Announces 42 Market Authorization Application 42 Kiacta 42 Submits Application 42 k Premarket Notification 42 Kissei Pharmaceutical 42 exclusive sublicense 42 Arikace 42 XENAZINE 42 assume operatorship 42 outlicensed 42 PrevOnco ™ 42 ViroChem Pharma Inc. 42 Novartis NVS Snapshot Report 42 Firdapse ™ amifampridine phosphate 42 Rhucin ® recombinant 42 Aclasta Reclast 42 Ceragenin TM technology 42 Combidex 42 ATPace TM 42 Eucreas 42 Alnara Pharmaceuticals 42 eSVS MESH 42 MK #B 42 Esbriet pirfenidone 42 Memryte 42 Biophan patent 42 premarketing 42 commercialize teduglutide outside 42 Krystexxa 42 TRANSDUR Bupivacaine 42 Simdax 42 covenant waivers 42 NanoCrystal technology 42 TFChem 42 Omnitrope 42 Prolacria 42 Alair System 42 faropenem medoxomil 42 chemosaturation system 42 GVAX Immunotherapies 42 STRIANT ® 42 Cimzia TM 42 BRILINTA 42 LUVENIQ 42 Basilea Toctino R 42 progesterone gel 42 RIGScan CR 42 PULSYS 42 Allegra Oral Suspension 42 Reloxin R 42 FlutiformTM 42 DepoBupivacaine TM 42 Veregen R 42 mesylate tablets approved 42 Approvals 42 Revolade 42 Praecis 42 aldehyde dehydrogenase ALDH2 deficiency 42 Atryn 42 Dynepo TM 42 Definitive Agreement 42 Sancuso 42 Zentaris 42 ESTRASORB R 42 Aegerion 42 PROMACTA ® 42 ELAPRASE 42 iii Cubist 42 prGCD 42 Apo AIMilano 42 Febuxostat 42 Veregen 42 SuperStitch ® 42 Poly ICR 42 peripheral vascular stent 42 Syntonix 42 subsidiary Glenmark Generics 42 AstraZeneca AZN.L 行情 42 flu vaccine Fluarix 42 ArPetrol Transaction 42 GlaxoSmithKline Tykerb 42 vitro diagnostic IVD 42 SUPPRELIN LA 42 incorporate CXA 42 Completion 42 Ceragenin ™ technology 42 Biogen Idec Tysabri 42 Miochol E 42 pivotal bioequivalence 42 Orazol 42 ANDAs abbreviated 42 Onalta ™ 42 valtorcitabine 42 Daewoong 42 IPM Wound Gel 42 injectable antibiotic 42 Ceplene R 42 VALSTAR 42 Phase III trials 42 Ceplene ® 42 IoGen 42 Collategene 42 GTC recombinant form 42 molecular imaging radiopharmaceutical 42 tolevamer 42 NYSE AMEX PLX 42 Prednisporin 42 aztreonam lysine 42 Phase IIb clinical trials 42 Sylvie Gregoire President 42 Qinnan PSC 42 NASDAQ PGNX 42 Apthera 42 CAMPATH 42 LO LOESTRIN FE 42 Genentech Roche 42 CVac 42 Sanctura XR 42 Xyotax 42 GSK Cervarix 42 AERx iDMS 42 biogeneric drugs 42 Luramist 42 Ruconest 42 PREOS 42 Medingo 42 Dificid 42 Inhibiton 42 DigiFab TM 42 PCA3 test 42 Investigational 42 Fampridine SR Acorda Therapeutics 42 ATryn R 42 Aeroflex stockholders 42 post menopausal osteoporosis 42 ReAble Therapeutics Inc. 42 Zavesca 42 Rongheng 42 BEXXAR 42 talactoferrin 42 Merck Arcoxia 42 Rotarix ® 42 recombinant thrombin 42 DIFICID ™ 42 Hummer Tengzhong 42 Exalgo TM 42 MediWound 42 k premarket 42 pancreatic enzyme replacement 42 CRMD# 42 Bioaccelerate compounds under 42 Generx ™ 42 consummating acquisitions 42 Entocort 42 Synvisc ONE 42 Cumulase 42 Zanaflex Capsules competition 42 Swiss drugmaker 42 Zolpidem Tartrate Tablets 42 Progen Pharmaceuticals 42 FIPB clearance 42 Amitiza ® 42 treat enlarged prostate 42 DAVANAT ® 42 WDEQ Permit 42 Topiramate Tablets 42 GED aPC 42 BYDUREON 42 Sanvar R 42 Sturgeon Upgrader 42 Fusilev 42 subsidiaries visit http:/www.apricusbio.com 42 Guidant vascular 42 Interpharm 42 Unifill TM syringe 42 MHLW 42 ASX PGL 42 Zelrix 42 Oncobionic 42 NADiA ProsVue 42 tramiprosate ALZHEMED TM 42 CORLUX CORT # 42 Angioblast 42 AMEX IVX LSE IVX.L 42 Loramyc ® 42 commercialization milestones 42 suburban St.Louis 42 MRC accreditation 42 ANDA approvals 42 Evithrom 42 OraTest R 42 Nexavar sorafenib tablets 42 Allovectin 7 ® 42 Vimpat ® lacosamide 42 spokeswoman Alison Marquiss 42 JUVISTA 42 L DOS# 42 Fanapt TM 42 MAXY alpha 42 bardoxolone 42 clearance 42 Chaim Lebovits President 41 THELIN 41 RIGScan ™ 41 Canvaxin 41 Fentanyl Taifun 41 Camvia 41 udenafil 41 statutory clearances 41 EFAPROXYN 41 Handok 41 Doliveux 41 TWYNSTA ® 41 CHDI Foundation 41 H3 Pharma 41 Anturol TM 41 ANDA 41 Salmedix 41 Pharmaxis 41 Galida 41 Troxatyl 41 Linjeta ™ 41 HuMax CD4 41 Votrient 41 Dermylex TM 41 ViaCyte 41 PDUFA date 41 PROLACRIA ™ 41 ZADAXIN ® 41 #D#C# 41 HPV vaccine Cervarix 41 Australian Therapeutic Goods 41 miconazole Lauriad R 41 PD2i Analyzer 41 ORBIT II 41 Fodosine TM 41 EvaMist 41 acyclovir Lauriad R 41 oral hydromorphone 41 carcinogenicity studies 41 OREXIGEN 41 Vicuron 41 antitrust immunity 41 Sycrest 41 IL# PE#QQR 41 CLIRS trial 41 MacroChem 41 methylnaltrexone 41 GA GCB 41 Scivanta Medical Corporation 41 BREAKYL 41 ATD gel 41 Atrigel 41 TriActiv 41 TRANSDUR Sufentanil 41 Allegra ® 41 Européenne Mark 41 Epitan 41 Vascular Wrap TM 41 FOLOTYN ® 41 Kyowa Pharmaceutical Industry 41 rasagiline tablets 41 Priority Review 41 velaglucerase alfa 41 Drug Eluting Stent System 41 OrCel R 41 treat atrial flutter 41 JunJing III 41 Phenoptin 41 iii GTx 41 indiplon capsules 41 regarding Heska 41 Velcade bortezomib 41 Evoltra R