FDA issues Complete Response Letter for Eliquis (BMS/Pfizer) in Stroke Prevention - 26-Jun-2012
The FDA has issued a Complete Response Letter regarding the New Drug Application for Eliquis (apixaban) from BMS/Pfizer for the Prevention of Stroke and Systemic Embolism in patients with nonvalvular atrial fibrillation. The FDA requests additional information on data management and verification from the ARISTOTLE trial. BMS and Pfizer will work closely with the FDA on the appropriate next steps for the Eliquis application. The FDA has not requested that the companies complete any new studies.
Related News
PROTECT-AF trial of Watchman LAAC (Boston Scientific) successful for Stroke Prevention
IQWiG report on Eliquis (BMS/Pfizer) for Stroke Prevention associated with Atrial Fibrillation
PREVAIL trial of Watchman LAAC (Boston Scientific) shows some benefits for AF patients
NICE recommends Eliquis (Pfizer/BMS) for Stroke Prevention
CE Mark granted to st Jude Medical for Amplatzer LAA Occluder
FDA approves Eliquis (BMS/Pfizer) to reduce the risk of Stroke and Systemic Embolism
Study of Pradaxa (Boehringer) for Atrial Fibrillation shows positive safety profile and efficacy
Sub Analysis of Eliquis (BMS/Pfizer)in ARISTOTLE trial show consistent reductions in Stroke and bleeding risk
Related Cardiology Information
Cardiology Clinical Guidelines
Atrial fibrillation: National clinical guideline for management in primary and secondary care
NICEHypertension: management of hypertension in adults in primary care
NICECardiology Clinical Trials
A Pilot Study of a Novel Technique for Cardiac Resynchronisation Therapy to Treat Heart Failure (LV-CONSEPT)
Clinicaltrials.gov 19 March 2013A Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-54452840 in Participants With Heart Failure and Anti-beta1-adrenergic Receptor Autoantibodies
Clinicaltrials.gov 22 February 2013Cardiology Medical Journal Abstracts
Local Versus Epidural Anesthesia in Fast-Track Abdominal Aortic Surgery
Journal of Cardiothoracic and Vascular Anesthesia 02 January 2013β-Blockers and Volatile Anesthetics May Attenuate Cardioprotection by Remote Preconditioning in Adult Cardiac Surgery: A Meta-analysis of 15 Randomized Trials
Journal of Cardiothoracic and Vascular Anesthesia 02 January 2013Cardiology Medical Apps
Cardiac CT imaging - Diagnosis of Cardiovascular disease
£3.99
Cardio3 ECHO Lite
Free
Related Cardiology Drugs
- TRANDATE TABLETS
- ADALAT LA 30 MG PROLONGED-RELEASE TABLETS
- CORGARD TABLETS 80MG
- AMIAS TABLETS
- ASASANTIN RETARD
- LOPRESOR (HYPERTENSION)
- FRAGMIN 10,000 IU/1 ML
- INSPRA 25MG & 50 MG FILM-COATED TABLETS
- WARFARIN
- SOTACOR TABLETS
- NEORECORMON (SOLUTION FOR INJECTION)
- APROTININ
- ELANTAN (ANGINA)
- COAPROVEL
- CO-AMILOFRUSE 20/2.5MG TABLETS
- TRIAPIN
- DOPAMINE 40 MG/ML STERILE CONCENTRATE
- CO-BETALOC
- CO-AMILOFRUSE 40/5MG TABLETS
- CAPOTEN TABLETS 25 MG & 50 MG
- OLMETEC PLUS FILM-COATED TABLETS
- ZANIDIP 20 MG TABLETS
- LIPOSTAT
- CARACE (CARDIAC FAILURE)
- EXFORGE 5MG/80MG, 5MG/160MG, 10MG/160MG FILM COATED TABLETS
- DEMSER
- NITROLINGUAL
- PERSANTIN 100 MG TABLETS
- ISOSORBIDE MONONITRATE 20MG TABLETS
- FRUMIL LS
- KONAKION
- CHOLESTAGEL FILM-COATED TABLETS
- ROGITINE
- FERROUS SULPHATE TABLETS, COMPOUND
- ARAMINE
- DISOPYRAMIDE
- ATENOLOL 25MG TABLETS
- OMACOR
- CLIVARINE
- HELIXATE
- GLYPRESSIN INJECTION
- RAPISCAN (REGADENOSON)
- SIMVADOR 10MG, 20MG, 40MG, 80MG
- SOTALOL HYDROCHLORIDE 80 MG AND 160MG TABLETS
- RAMIPRIL 10MG TABLETS
- LABETALOL HYDROCHLORIDE (HYPERTENSION)
- ZAPAIN
- STREPTASE 250,000 IU AND 750,000 IU
- NEOSPECT
- ISOTARD XL
- TRANDATE INJECTION
- ANGIOPINE MR
- CARDENE SR 30 AND 45MG
- UNIVER 240MG PROLONGED RELEASE CAPSULES
- PREGADAY
- XISMOX 60 XL PROLONGED RELEASE TABLETS
- NOVOSEVEN
- HYTRIN
- OLBETAM CAPSULES 250
- CELIPROLOL
- PRONESTYL
- LOPID 300MG HARD CAPSULES & 600MG FILM-COATED TABLETS
- ZOCOR 10MG, 20MG, 40MG AND 80MG FILM-COATED TABLETS
- COZAAR 2.5 MG/ML POWDER AND SOLVENT FOR ORAL SUSPENSION
- KALTEN
- TEVETEN 300MG AND 600MG FILM-COATED TABLETS
- EUCARDIC 25MG TABLETS
- HEXOPAL
- HAEMATE P 500 AND 1000 IU
- BEZALIP MONO / CALBERZOL XL
- DYAZIDE
- CALCIUM CHLORIDE INTRAVENOUS INFUSION, 10% W/V
- CORDARONE X INTRAVENOUS
- SECADREX
- TAMBOCOR XL CAPSULES
- PAROVEN
- DILTIAZEM HYDROCHLORIDE TABLETS 60MG
- ANGITIL SR /XL
- SIMVASTATIN 10MG FILM-COATED TABLETS
- HALF INDERAL
- COVERSYL ARGININE PLUS TABLETS
- DIGOXIN INJECTION BP 500 MICROGRAMS/2ML
- PERDIX
- ARYTHMOL
- TOREM
- CAPTO-CO
- CYKLOKAPRON INJECTION
- CATAPRES AMPOULES
- INDERAL LA 160MG
- KABIKINASE
- ISMO RETARD
- COLESTID
- BENDROFLUAZIDE
- HYDRALAZINE AMPOULES
- PARMID XL 5 MG PROLONGED RELEASE TABLETS
- OPTISON
- REVASC
- PRESTIM TABLETS
- RANEXA PROLONGED-RELEASE TABLETS
- SOLIRIS SOLUTION FOR INFUSION
- ISTIN
- FLECAINIDE
- LOPRESOR SR
- SLOW TRASICOR
- TILDIEM 60MG MODIFIED-RELEASE TABLETS
- DEPONIT 5
- CORACTEN XL (ANGINA)
- HYDROSALURIC
- DIUREXAN TABLETS
- UNIVER 180MG PROLONGED RELEASE CAPSULES
- TRISENOX SOLUTION FOR INFUSION
- TAMBOCOR INJECTION
- ORGARAN
- TENORMIN INJECTION 0.5MG/ML
- ZESTRIL 2.5MG, 5MG, 10MG, AND 20MG TABLETS.
- ISMELIN
- TAMBOCOR TABLETS
- LASIX INJECTION 20MG/2ML
- BEZALIP 200MG TABLETS
- ACTILYSE CATHFLO 2 MG
- MONOZIDE 10
- SYTRON
- METENIX
- MINITRAN
- ELANTAN (HEART FAILURE)
- INNOVACE
- RASILEZ TABLETS
- GLYTRIN
- NATRILIX SR
- LOPRESOR (ANGINA)
- INOSITOL NICOTINATE
- QUIXIDAR 2.5 MG/0.5 ML
- DIPYRIDAMOLE
- CORDARONE 100MG AND 200MG TABLETS
- AMIODARONE
- ADIZEM-XL
- METHYLDOPA
- SIMVASTATIN 20MG/5ML ORAL SUSPENSION
- VERTAB SR 240MG
- SECTRAL 100MG AND 200MG
- PRESCAL
- OMNIPAQUE
- RYTHMODAN
- FRU-CO
- SOLOC 5 MG TABLETS
- MODURET 25
- TANATRIL
- ISIB
- SEVIKAR
- ATENOLOL 100MG
- VASOXINE
- REPLENINE
- DEBRISOQUINE
- TENORMIN SYRUP
- LIPOBAY
- LASILACTONE
- LISINOPRIL 10MG TABLETS
- FERROUS SULPHATE TABLETS BP 200MG
- UNIVER 120MG PROLONGED RELEASE CAPSULES
- APRINOX
- EMCOR
- ACETAZOLAMIDE 250MG TABLETS
- NYOGEL 0.1% EYE GEL
- FLOLAN
- ASPIRIN 75 MG GASTRO-RESISTANT TABLETS
- APRESOLINE TABLETS 25 MG
- SECURON SR
- NIMOTOP 0.02% SOLUTION FOR INFUSION
- AMIODARONE 100MG TABLETS
- VENOFER
- BETA-ADALAT
- AMIODARONE 200MG TABLETS
- ZESTORETIC
- MYOVIEW
- NEUPOGEN
- INTEGRILIN
- EUDEMINE (HYPERTENSION)
- TRANSIDERM-NITRO 5 AND 10
- LANOXIN
- DOPACARD
- ENALAPRIL MALEATE/HYDROCHLOROTHIAZIDE 20/12.5MG TABLETS
- NEO-NACLEX
- HYGROTON
- OCTANATE 100IU/ML
- ADALAT LA 20 MG PROLONGED-RELEASE TABLETS
- ADALAT
- NITRONAL
- VERAPAMIL (ANGINA)
- PRITOR
- MOTENS TABLETS
- TARKA
- TEKAMLO
- GRANOCYTE
- INDEREX
- ALDACTONE 25MG, 50MG AND 100MG TABLETS
- APROVEL FILM-COATED TABLETS (SANOFI-AVENTIS BRISTOL-MYERS SQUIBB SNC)
- CANDESARTAN CILEXETIL 16 MG TABLETS
- MONOCOR
- TENORET 50
- MODALIM
- SUPRALIP 160
- DIOVAN 40MG FILM-COATED TABLETS
- VERAPAMIL (HYPERTENSION)
- TICLID
- CARDURA XL TABLETS
- TILDIEM LA 200/300MG PROLONGED-RELEASE CAPSULES
- PROPRANOLOL
- OXPRENOLOL
- ODRIK
- BENEFIX 250 IU / 500 IU / 1 000 IU / 2 000 IU
- SLOZEM
- TENSIPINE MR
- CELECTOL 200 TABLETS
- NU-SEALS 75
- ANGETTES 75
- FIBROGAMMIN P
- PROCORALAN
- EPINEPHRINE (ADRENALINE) INJECTION 1:10,000
- KALSPARE
- SINTHROME
- PEDEA 5 MG/ML SOLUTION FOR INJECTION
- REOPRO
- APRESOLINE AMPOULES 20 MG
- INDIPAM XL
- LEXPEC
- SIMVASTATIN 40MG
- EPHEDRINE HYDROCHLORIDE
- INDERETIC
- AMIL-CO
- ALPHAPARIN
- VISKEN TABLETS 15 MG
- ELANTAN LA (ANGINA)
- CHEMYDUR 60XL
- TENBEN
- ADIZEM-SR TABLETS
- PERCUTOL
- LISINOPRIL 20MG TABLETS
- ENALAPRIL MALEATE 5MG TABLETS
- BEDRANOL 80MG SR CAPSULES
- CORGARETIC 40
- LEUCOMAX
- BEDRANOL 160MG SR CAPSULES
- DIXARIT (MENOPAUSAL DISORDERS)
- FRUSENE
- BISOPROLOL 2.5MG/5MG/10MG FILM COATED TABLET
- LOSARTAN POTASSIUM 50 MG FILM-COATED TABLETS
- FERROUS GLUCONATE 300MG TABLETS
- COVERSYL ARGININE
- ZANIDIP 10 MG TABLETS
- REFACTO AF POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- ALDACTIDE 25MG AND 50MG TABLETS
- ALDOMET TABLETS 250 MG
- RYTHMODAN RETARD
- LERCANIDIPINE HYDROCHLORIDE 20 MG FILM-COATED TABLETS
- NIFEDIPINE
- LISINOPRIL 2.5MG TABLETS
- KOGENATE BAYER 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION (MEDIMOP)
- EUCARDIC 12.5MG TABLETS
- METOPIRONE
- NITRO-DUR
- DILZEM SR
- OPILON
- VASCACE TABLETS
- DOBUTAMINE 5 MG/ML, SOLUTION FOR INFUSION
- ADENOCOR
- PLENDIL 2.5MG, PLENDIL 5MG AND PLENDIL 10MG
- FELOTENS XL TABLETS
- COZAAR 12.5 MG, 25 MG, 50 MG AND 100 MG FILM-COATED TABLETS
- FRUSOL
- ACCURETIC 10/12.5MG TABLETS
- ISOKET INFUSION
- EZETROL TABLETS
- GOPTEN
- PHARMADREAMS - ENALAPRIL 10MG TABLETS
- PHARMADREAMS - ENALAPRIL 20MG TABLETS
- LESCOL (FLUVASTATIN* SODIUM) 20 MG AND 40 MG CAPSULES
- CLOPIDOGREL 75 MG FILM-COATED TABLETS
- CARACE 20 PLUS TABLETS
- AGGRASTAT
- DIOVAN 320MG FILM-COATED TABLETS
- COZAAR - COMP 50/12.5MG, 100/12.5MG AND 100/25MG FILM-COATED TABLETS
- PERSANTIN RETARD 200 MG
- QUIXIDAR 1.5 ML/0.3 ML
- NEPHRIL
- NIMOTOP 30MG TABLETS
- TRENTAL 400
- CAPTOPRIL 12.5 MG, 25 MG AND 50 MG TABLETS
- HYPOLOC 5 MG TABLETS
- BETIM 10MG TABLETS
- ANGIOPINE
- AMLODIPINE 10MG TABLETS
- ADALAT 5
- IMAZIN XL
- REVATIO 20 MG FILM-COATED TABLETS
- PHENYLEPHRINE INJECTION 1%
- TRASIDREX
- TRACLEER
- INNOZIDE
- TILDIEM RETARD 90MG PROLONGED-RELEASE TABLETS, TILDIEM RETARD 120MG PROLONGED-RELEASE TABLETS
- VISKALDIX TABLETS
- SIMVASTATIN 40MG/5ML ORAL SUSPENSION
- NEBILET 5 MG TABLETS
- TENORETIC
- REFLUDAN 50 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION
- TENORMIN LS 50MG TABLETS
- CARDENE 20 AND 30MG
- PRIMACOR 1MG/ML SOLUTION FOR INJECTION
- IKOREL
- TRITACE 2.5MG TABLETS
- PLAVIX 75MG TABLETS
- ACTILYSE
- BARATOL
- METOPROLOL TARTRATE TABLETS BP 100MG
- SIMVASTATIN 80MG
- FIRAZYR SOLUTION FOR INJECTION
- CAPOZIDE TABLETS
- TENIF
- LIPANTIL MICRO
- NITROCINE
- HYDRALAZINE TABLETS
- DIOVAN 40MG CAPSULES
- CATAPRES TABLETS 300MCG
- EPINEPHRINE [ADRENALINE] 1 IN 10, 000
- MONOMAX SR
- NATRILIX
- FORTIPINE LA 40MG MODIFIED-RELEASE TABLETS
- SPIRONOLACTONE 100MG TABLETS
- GEMFIBROZIL
- ATENOLOL 50MG FILM-COATED TABLETS
- PERSANTIN AMPOULES 10 MG/2 ML SOLUTION FOR INFUSION
- AMLODIPINE 5MG TABLETS
- MULTAQ 400MG TABLETS
- HEPSAL
- FERROUS SULPHATE ORAL SOLUTION
- XIGRIS SOLUTION FOR INFUSION
- ADIPINE MR
- TRIAM-CO
- ADRENALINE [EPINEPHRINE] 1 IN 1,000
- BETALOC I.V. INJECTION
- KERLONE
- STARIL (CARDIAC FAILURE)
- ADVATE SOLUTION FOR INJECTION
- STROMBA
- NAVISPARE
- CO-AMILOFRUSE TABLETS 5/40MG
- SUSCARD BUCCAL
- CRESTOR 5MG, 10MG, 20MG AND 40MG FILM-COATED TABLETS
- MODURETIC
- DIGOXIN TABLETS BP 62.5MCG, 125MCG, 250MCG
- ACCUPRO TABLETS 5MG, 10MG, 20MG & 40MG
- ZEMTARD XL
- COVERSYL (HYPERTENSION)
- MONIT
- CARDICOR 1.25MG, 2.5MG, 3.75MG, 5MG, 7.5MG, 10MG FILM COATED TABLETS
- ADIZEM-SR CAPSULES
- HEPARIN CALCIUM 25,000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION
- MEXITIL
- VISKEN TABLETS 5 MG
- IMDUR
- ACEBUTOLOL 100MG CAPSULES
- LONITEN
- TELMISARTAN ACTAVIS 20 MG TABLETS
- CELECTOL 400 TABLETS
- VIAZEM XL 120MG / 180MG / 240MG / 300MG / 360MG
- CATAPRES TABLETS 100MCG
- ADCIRCA
- NITROMIN
- FRUMIL
- ANGIOPINE LA
- GLYCERYL TRINITRATE
- SYSCOR MR
- GLYCERYL TRINITRATE INJECTION
- PLETAL TABLETS
- LIPITOR 10MG, 20MG, 40MG, 80MG TABLETS
- DYTAC 50MG CAPSULES
- NAVIDREX
- INDOCID PDA
- SECTRAL 400MG TABLETS
- LESCOL XL 80 MG PROLONGED RELEASE TABLETS
- EUCARDIC 6.25MG TABLETS
- ISOKET RETARD
- DOBUTAMINE CONCENTRATE 250MG/20ML
- VERAPAMIL (SVTS)
- TRITACE TABLET TITRATION PACK
- CO-AMILOZIDE (AMILORIDE, HYDROCHLOROTHIAZIDE)
- CENTYL K
- AMLOSTIN 10MG
Advert for Healthcare Professionals only