REGULATORY HISTORY OF SIGNIFICANT EVENTS |
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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 |
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|
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 |