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**

**[\[PART 1 OF 2\]]{.underline}**

SECTION 1: **Draft Questions to the Committee
\[[Word](../2005-4092B1_01_02-FDA-Draft-Questions.doc)\]
\[[PDF](../2005-4092B1_01_02-FDA-Draft-Questions.pdf)\]
\[[HTML](../2005-4092B1_01_02-FDA-Draft-Questions.htm)\]**

SECTION 2:

> **NDA 20-838/S-022
> \[[Word](../2005-4092B1_01_03-FDA-Clinical-Review-S022.doc)\]
> \[[PDF](../2005-4092B1_01_03-FDA-Clinical-Review-S022.pdf)\]\[[HTML](../2005-4092B1_01_03-FDA-Clinical-Review-S022.htm)\]**
>
> **CHARM-Added \[[PDF Pages
> 001-099](../2005-4092B1_01_03-FDA-Clinical-Review-S022-01-Pages_001-099.pdf)\]**
>
> **(Clinical Review) \[[PDF Pages
> 100-199](../2005-4092B1_01_03-FDA-Clinical-Review-S022-02-Pages_100-199.pdf)\]**
>
> **\[[PDF Pages
> 200-299](../2005-4092B1_01_03-FDA-Clinical-Review-S022-03-Pages_200-299.pdf)\]**
>
> **\[[PDF Pages
> 300-399](../2005-4092B1_01_03-FDA-Clinical-Review-S022-04-Pages_300-398.pdf)\]**

SECTION 3: **NDA 20-838/S-022
\[[Word](../2005-4092B1_01_04-FDA-Statistical%20-Review-S022.doc)\]
\[[PDF](../2005-4092B1_01_04-FDA-Statistical%20-Review-S022.pdf)\]
\[[HTML](../2005-4092B1_01_04-FDA-Statistical%20-Review-S022.htm)\]**

> **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**

**[\[PART 2 OF 2\]]{.underline}**

SECTION 4: **NDA 20-838/S-024
\[[Word](../2005-4092B1_01_05-FDA-Clinical-Review-S024.doc)\]
\[[PDF](../2005-4092B1_01_05-FDA-Clinical-Review-S024.pdf)\]
\[[HTML](../2005-4092B1_01_05-FDA-Clinical-Review-S024.htm)\]**

**CHARM-Alternative \[[PDF Pages
001-099](../2005-4092B1_01_05-FDA-Clinical-Review-S024-01-Pages_001-099.pdf)\]**

> **(Clinical Review) \[[PDF Pages
> 001-099](../2005-4092B1_01_05-FDA-Clinical-Review-S024-02-Pages_100-199.pdf)\]**

**\[[PDF Pages
001-099](../2005-4092B1_01_05-FDA-Clinical-Review-S024-03-Pages_200-241.pdf)\]**

SECTION 5: **NDA 20-838/S-025
\[[Word](../2005-4092B1_01_06-FDA-Clinical-Review-S025.doc)\]
\[[PDF](../2005-4092B1_01_06-FDA-Clinical-Review-S025.pdf)\]
\[[HTML](../2005-4092B1_01_06-FDA-Clinical-Review-S025.htm)\]**

**CHARM-Preserved \]**

> **(Clinical Review)**

SECTION 6: **NDA 20-838
\[[Word](../2005-4092B1_01_07-FDA-Statistical-Review-S022-S024-S025.doc)\]
\[[PDF](../2005-4092B1_01_07-FDA-Statistical-Review-S022-S024-S025.pdf)\]
\[[HTML](../2005-4092B1_01_07-FDA-Statistical-Review-S022-S024-S025.htm)\]**

> **S-022, S-024, S-025**
>
> **(Statistical Review)**