REGULATORY HISTORY OF SIGNIFICANT EVENTS

Date

Event

Details

13 July 1995

Original submission of IND 48,395

N/A

09 February 1996

End of Phase I meeting

Clinical development planning

03 May 1996

End of Phase I meeting

Clinical development planning

29 August 1996

End of Phase II meeting

Clinical design for efficacy, long-term safety studies in RA & OA

15 October 1996

End of Phase II meeting

CMC; clinical design for renal studies, platelet studies

04 November 1996

End of Phase II meeting

Clinical design for renal studies and anti-hypertensive drug-interaction studies

12 December 1996

End of Phase II meeting

Labeling, study designs, and statistical considerations

18 February 1997

End of Phase II meeting

Dose-finding. Dose response, indications

22 October 1997

Pre-Phase III meeting

Clinical design of long-term GI studies for COX-2 agents

13 January 1998

Pre-NDA meeting

OA/RA indications

12 February 1999

New protocols submitted

CLASS 1 and CLASS 2 studies initiated (Ph IV commitment)

29 March 1999

Pre-NDA meeting

FAP indication

13 September 2000

Pre-NDA meeting

New pain indications

05 January 2005

Response to FDA Information Request

Alzheimer’s Study 001 with addendum (cross reference IND 53,125)

REGULATORY HISTORY OF SIGNIFICANT EVENTS

Submission Date

Submission Type

Details

Approval Date

29 June 1998

Original NDA

Original New Drug Application

Indications: osteoarthritis and rheumatoid arthritis in adults

31 December 1998

1 December 1998

N/A

Arthritis Advisory Committee meeting held – data presented for celecoxib and NDA granted priority review

N/A

15 October 1999

Labeling Supplement – CBE

Labeling change: strengthen WARNINGS/Anaphylactoid Reactions

Changes Being Effected

10 June 1999

Labeling Supplement – CBE

Labeling change: strengthen PRECAUTIONS (warfarin co-administration with Celebrex)

Changes Being Effected

24 June 1999

Efficacy Supplement (S-007)

New indication: to reduce the number of adenomatous colorectal polyps in Familial Adenomatous Polyposis (FAP) in patients as an adjunct to usual care. (Note: this indication also filed under NDA 21-156)

23 December 1999

25 April 2000

Labeling Supplement (S-008)

Labeling change: PRECAUTIONS/Pregnancy subsection.

1 December 2000

12 June 2000

Labeling Supplement (S-009)

Labeling change (CLASS): Warnings, Precautions, Adverse Events, and Clinical Studies sections based on a large gastrointestinal outcome study for Celebrex.

7 June 2002

18 December 2000

Efficacy Supplement (S-010)

New indications: management of acute pain in adults and the treatment of primary dysmenorrhea.

18 October 2001

7-8 February 2001

FDA Advisory Committee Meeting

Arthritis Advisory Committee, regarding proposed CLASS labeling supplement S-009

N/A

26 September 2001

General Correspondence - Supplement (S-009)

Formal Dispute Resolution request regarding CLASS labeling

FDA Response to Dispute Resolution (Janet Woodcock) dated 7 December 2001

7 December 2001

N/A

Arthritis Advisory Committee meeting held - for an update on the safety of COX-2 inhibitors which included a presentation of the CLASS data

N/A

12 December 2001

Efficacy Supplement (S-013)

New dosage: 400 mg strength capsules and addition of certain container/closure systems

29 August 2002

9 August 2004

Labeling Supplement (S-017) -

CBE

Labeling change: PRECAUTIONS/Drug Interactions, (Warfarin)

Changes Being Effected