DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service: Celebrex Letter

June 7, 2002 - Celebrex Letters

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Food and Drug Administration Rockville MD 20857

NDA 20-998/S-009

Dear Dr. Essig:

Please refer to your supplemental new drug application dated June 12, 2000, received June 14, 2000, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Celebrex^TM (celecoxib capsules) Capsules, 100 mg and 200 mg.

We acknowledge receipt of your submissions dated February 04; March 21; April 08, 17, and 23; May 01, 09, and 17, 2002. Your submission of December 20, 2001 constituted a complete response to our April 12, 2001 action letter.

This supplemental new drug application provides for changes to the Warnings, Precautions, Adverse Events, and Clinical Studies sections of the labeling based on a large gastrointestinal outcome study for Celebrex.

We have completed the review of this supplemental application, as amended, and have concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the agreed upon enclosed labeling text. Accordingly, the supplemental application is approved effective on the date of this letter.

The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert).

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 20-998/S-009." Approval of this submission by FDA is not required before the labeling is used.

NDA 20-998/S-009
Page 2

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:

Please submit one market package of the drug product when it is available. 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, call Barbara Gould, Project Manager, at (301) 827-2090.

Sincerely,

{See appended electronic signature page}

Lawrence Goldkind, M.D.
Deputy Division Director
Division of Anti-Inflammatory, Analgesic and Ophthalmic
Drug Products
Office of Drug Evaluation V
Center for Drug Evaluation and Research

Enclosure

/s/

Lawrence Goldkind
6/7/02 09:16:32 AM

Weitz & Luxenberg is no longer accepting Celebrex cases.

see also:

Celebrex Letters June 7, 2002 Celebrex Letters - June 7, 2002
Official FDA Letter Concerning the Celebrex Labels from June 7, 2002

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

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