NDA 21-341

BEXTRA (Valdecoxib, 10 and 20 mg Tablet)

REGULATORY HISTORY OF SIGNIFICANT EVENTS

Submission Date

Submission Type

Details

Approval Date

16 January 2001

Original NDA

Original New Drug Application

16 November 2001

19 June 2002

Labeling supplement (S-001) CBE

Modification of text of the Professional Sample carton and sample packaging for the Bextra 10 mg tablet to include the phrase "Once Daily" in association with the product name.

NA letter

24 January 2003

25 October 2002

Labeling supplement (S-002) - CBE

Addition of a new contraindication sentence for patients with a history of allergic reactions to sulfonamides.

The addition of a new WARNINGS section: Serious Skin Reactions.

The addition of a new sentence to the Warnings-Anaphylactoid Reactions section. The addition of a new paragraph in the ADVERSE REACTIONS section: Postmarketing Experience.

1 November 2002

6 February 2003

Labeling supplement (S-001) CBE

Withdrawal of unapproved supplemental new drug application for Bextra (valdecoxib sodium) 10 mg tablets.

N/A

24 June 2003

Labeling Supplement (SE-8)

Modification of text of the Product Information to include information from five new drug-drug interaction (DDI) studies conducted with valdecoxib and the following medications: omeprazole, ethinyl estradiol/norethindrone (35 mcg/1 mg combination), phenytoin, diazepam, and glyburide.

23 April 2004

11 August 2003

Labeling Supplement (S-004) - CBE

Draft of the Patient Summary of information for Bextra®.

AE letter

17 March 2004

19 August 2004

Labeling Supplement (S-006) - CBE

Modification of text under WARNINGS

Serious Skin Reactions and PRECAUTIONS, Information for patients.

AE letter

14 September 2004

28 October 2004,

12 November 2004,

23 November 2004 (via e-mail)

Labeling Supplement (S-006) - CBE

Addition of Black Box Warning on SSRs, and revised text under the Serious Skin Reaction paragraph of the WARNINGS section. Addition of text discussing safety studies in post-surgical patients (Investigational use) under CLINICAL STUDIES section.

The addition of text stating contraindication for the treatment of post-operative pain immediately following coronary artery bypass graft (CABG) surgery under the CONTRAINDICATIONS section.

The addition of text under Coronary Artery Bypass Graft paragraph under WARNINGS section.

24 November 2004