FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

 

Cardiovascular and Renal Drugs Advisory Committee Meeting

February 24, 2005

 

FDA Center for Drug Evaluation and Research

Advisory Committee Conference Room

 5630 Fishers Lane, Rockville, MD

           

NDA 20-838/S-022, S-024, S-025

ATACAND® (candesartan cilexetil) Tablets - AstraZeneca LP

For Use in the Treatment of Patients with Congestive Heart Failure

 

Division of Cardiovascular and Renal Drug Products

Background Package

 

TABLE OF CONTENTS

 

[PART 1 OF 2]

 

 

 

SECTION 1:                            Draft Questions to the Committee     [Word] [PDF] [HTML]

 

 

 

SECTION 2:                           

NDA 20-838/S-022     [Word] [PDF][HTML]

CHARM-Added                                 [PDF Pages 001-099]

(Clinical Review)                                [PDF Pages 100-199]

                                                [PDF Pages 200-299]

[PDF Pages 300-399]

 

 

SECTION 3:                            NDA 20-838/S-022     [Word] [PDF] [HTML]

CHARM-Added

(Statistical Review)

 


FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

 

Cardiovascular and Renal Drugs Advisory Committee Meeting

February 24, 2005

 

FDA Center for Drug Evaluation and Research

Advisory Committee Conference Room

 5630 Fishers Lane, Rockville, MD

           

NDA 20-838/S-022, S-024, S-025

ATACAND® (candesartan cilexetil) Tablets - AstraZeneca LP

For Use in the Treatment of Patients with Congestive Heart Failure

 

Division of Cardiovascular and Renal Drug Products

Background Package

 

TABLE OF CONTENTS

 

[PART 2 OF 2]

 

 

 

 

SECTION 4:                            NDA 20-838/S-024     [Word] [PDF] [HTML]

                                                CHARM-Alternative [PDF Pages 001-099]

(Clinical Review)                    [PDF Pages 001-099]

                                                                                                [PDF Pages 001-099]

 

 

SECTION 5:                            NDA 20-838/S-025     [Word] [PDF] [HTML]

                                                CHARM-Preserved  ]

(Clinical Review)       

 

 

SECTION 6:                            NDA 20-838     [Word] [PDF] [HTML]

S-022, S-024, S-025

(Statistical Review)