DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

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Food and Drug Administration
Rockville, MD 20857

NDA 20-998/S-016

Dear Mr. Elliott:

Please refer to your supplemental new drug application dated October 8, 2003, received October 9, 2003, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Celebrex® (celecoxib) capsules, 100 mg, 200 mg and 400 mg.

We acknowledge receipt of your submission dated October 8, 2003. This “Changes Being Effected in 30 days” supplemental new drug application provides for an additional statement to the PRECAUTIONS – Nursing Mothers section of the label.

We completed our review of this application, as amended. This application is approved, effective on the date of this letter, for use as recommended in the agreed-upon labeling text and with the minor editorial revisions indicated in the enclosed labeling.

The changes are as follows:

1. The sentence "It is not known whether this drug is excreted in human milk" has been deleted from the PRECAUTIONS – Nursing Mothers section.

2. The sentence "Limited data from one subject indicate that celecoxib is also excreted in human milk" has been added to the PRECAUTIONS – Nursing Mothers section.

3. Under the WARNINGS – Pregnancy section, the parenthetical remark (see PRECAUTIONS – Pregnancy) has been added.

The final printed labeling (FPL) must be identical, and include the minor editorial revisions indicated, to the enclosed labeling (text for the package insert). These revisions are terms of the approval of this application.

Please submit the FPL electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format – NDA. Alternatively, you may submit 20 paper copies of the FPL as soon as it is available, in no case more than 30 days after it is printed. Please individually mount 15 of the copies on heavy-weight paper or similar material. For administrative purposes, this submission should be designated "FPL for approved supplement NDA 20-998/S-016." Approval of this submission by FDA is not required before the labeling is used.

NDA 20-998/S-016
Page 2

If you issue a letter communicating important information about this drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to the following address:

We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81).

If you have any questions, please call Ms. Jane A. Dean, RN, MSN, Regulatory Project Manager, at (301) 827-2090.

Sincerely,

{See appended electronic signature page}

Brian E. Harvey, MD, PhD
Acting Director
Division of Anti-Inflammatory, Analgesic and
Ophthalmic Drug Products, HFD-550
Center for Drug Evaluation and Research
Office of Drug Evaluation V

Enclosure

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This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
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/s/
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Brian Harvey
1/9/04 01:46:27 PM

Weitz & Luxenberg is no longer accepting Celebrex cases.

see also:

Celebrex Letter December 23, 1999 Celebrex Letter December 23, 1999
Department of Health and Human Services Letter Regarding Celebrex

FDA Celebrex Letters January 9 Celebrex Lawyers - FDA Celebrex Letters January 9, 2004
FDA Celebrex Letters January 9, 2004 - Is Your Life in Danger?

Letters FDA Celebrex Letters
FDA Letters for the New Drug Applications of Celebrex