DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

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Food and Drug Administration
Rockville MD 20857

NDA 20-998/S-010

Dear Dr. Begley:

Please refer to your supplemental new drug application dated December 18, 2000, received December 19, 2000, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for CelebrexTM (celecoxib capsule) Capsules 100 mg, and 200 mg.

We acknowledge receipt of your submissions dated June 14, September 24, and October 03, 2001.

This supplemental new drug application provides for the use of CelebrexTM (celecoxib capsule) Capsules 100 mg, and 200 mg for the management of acute pain in adults and the treatment of primary dysmenorrhea.

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-010." Approval of this submission by FDA is not required before the labeling is used.

Be advised that, as of April 1, 1999, all applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred (63 FR 66632). We are waiving the pediatric study requirement for this action on this application.

In addition, please submit three copies of the introductory

NDA 20-998/S-010
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use for this product. All proposed materials should be submitted in draft or mock-up form, not final print. Please submit one copy to this Division and two copies of both the promotional materials and the package insert directly to:

Division of Drug Marketing, Advertising, and Communications, HFD-42
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

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

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.

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

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