Administrative Reviews (Project Manager, ADRA) (indicate date of each review)

N/A

General Information

v      Actions

·         Proposed action

(x) AP   ( ) TA   ( ) AE   ( ) NA

·         Previous actions (specify type and date for each action taken)

AE (6/24/03

·         Status of advertising (approvals only)

( ) Materials requested in AP Letter

( ) Reviewed for Subpart H

v      Public communications

·         Press Office notified of action (approval only)

( ) Yes   (x) Not applicable

·         Indicate what types (if any) of information dissemination are anticipated

(x) None

( ) Press Release

( ) Talk Paper

( ) Dear Health Care Professional Letter

v      Labeling (package insert, patient package insert (if applicable), MedGuide (if applicable)

·         Division’s proposed labeling (only if generated after latest applicant submission of labeling)

·         Most recent applicant-proposed labeling

8/20/03

·         Original applicant-proposed labeling

See AE Package Tab D

·         Labeling reviews (including DDMAC, Office of Drug Safety trade name review, nomenclature reviews) and minutes of labeling meetings (indicate dates of reviews and meetings)

DSRCD/ 7-24-03

DMETS/ 7-29-03

·         Other relevant labeling (e.g., most recent 3 in class, class labeling)

N/A

v      Labels (immediate container & carton labels)

·         Division proposed (only if generated after latest applicant submission

N/A

·         Applicant proposed

7/3/03

·         Reviews

See above reviews dated 7/24/03 and 7/29/03

v      Post-marketing commitments

·         Agency request for post-marketing commitments

·         Documentation of discussions and/or agreements relating to post-marketing commitments

v      Outgoing correspondence (i.e., letters, E-mails, faxes)

Resubmission AK letter 7/15/03

v      Memoranda and Telecons

v      Minutes of Meetings

See AE Package Tab S

·         EOP2 meeting (indicate date)

·         re-NDA meeting (indicate date)

·         Pre-Approval Safety Conference (indicate date; approvals only)

·         Other

v      Advisory Committee Meeting

N/A

·         Date of Meeting

·         48-hour alert

v      Federal Register Notices, DESI documents, NAS, NRC (if any are applicable)

N/A