DEPARTMENT OF HEALTH & HUMAN SERVICES NDA Public Health Service

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Food and Drug Administration Rockville MD 20857

NDA 21-156/S-001
NDA 21-156/S-002

Pharmacia Corporation
Attention: Frederick F. Piszkiewicz
Senior Manager, CMC
4901 Searle Parkway
Skokie, IL 60077

Dear Mr. Piszkiewicz:

Please refer to your supplemental new drug applications dated December 12, 2001, received December 13, 2001, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Celebrex® (celecoxib) Capsules.

We acknowledge receipt of your submissions dated April 26, June 10, July 1, August 14, August 26, and August 29, 2002.

Your submission of April 26, 2002 constituted a complete response to our April 12, 2002 action letter.

These supplemental new drug applications provide for the addition of a 400 mg strength to the currently approved strength and the addition of certain container/closure systems for celecoxib 400 mg capsules.

We have completed the review of these applications, as amended. These applications are approved, effective on the date of this letter for use as recommended in the agreed-upon labeling text.

The final printed labeling (FPL) must be identical to the submitted draft labeling (package insert submitted August 29, 2002, immediate container and carton labeling submitted July 1, 2002).

Please submit the copies of final printed labeling (FPL) electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format - NDA (January 1999). Alternatively, you may submit 20 paper copies of the FPL as soon as it is available but no more than 30 days after it is printed. Please individually mount ten of the copies on heavy-weight paper or similar material. For administrative purposes, this submission should be designated "FPL for approved supplement NDA 21-156/S-001 and NDA 21-156/S-002." Approval of this submission by FDA is not required before the labeling is used.

If a letter communicating important information about this drug product (i.e., a "Dear Health Care Professional" letter) is issued to physicians and others responsible for patient care, we request that you submit a copy of the letter to this NDA and a copy to the following address:

MEDWATCH, HF-2
FDA
5600 Fishers Lane
Rockville, MD 20857

We remind you that you must comply with the requirements for an approved NDA set forth under 21 CFR 314.80 and 314.81.

If you have any questions, please call Brian Strongin, R.Ph., M.B.A., Regulatory Health Project Manager, at 301-827-7310.

Sincerely,

{See appended electronic signature page}

Victor F. C. Raczkowski, M.D., M.Sc.
Acting Director
Division of Gastrointestinal & Coagulation Drug Products
Office of Drug Evaluation III
Center for Drug Evaluation and Research

This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.

/s/

Victor Raczkowski
8/29/02 04:48:00 PM

Weitz & Luxenberg is no longer accepting Celebrex cases.

see also:

Celebrex NDA Letter August 29, 2002 Celebrex NDA Letter August 29, 2002
Department of Health & Human Services NDA Letter Regarding Celebrex

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

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