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 Product Approval Information

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

April 1, 2003

Our Reference No.:103772/5032

Stella S. Jones, Ph.D.
Centocor, Inc.
200 Great Valley Parkway
Malvern, PA 10355-1307

Dear Dr. Jones:

Your request to supplement your biologics license application for Infliximab to expand the indication to include reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn’s disease has been approved.

We approved your biologics license application for the Crohn’s disease indication under the regulations for accelerated approval of biological products for serious or life-threatening illnesses (21 CFR 601 Subpart E). As described in our letter dated August 24, 1998, that approval required you to complete certain specified studies. In our approval letter for BL 103772/5012, we acknowledged that you fulfilled part of your commitment made under 21 CFR 601.41 to complete a randomized, double-blind, placebo-controlled clinical study(s) to evaluate safety and efficacy of continued use of Infliximab for maintaining a sustained clinical outcome in patients with moderately to severely active Crohn’s disease. The approval of BL 103772/5032 fulfills your commitment to conduct a randomized, double-blind, placebo-controlled clinical study to evaluate safety and efficacy of continued used of Infliximab for maintaining a sustained clinical outcome in patients with draining enterocutaneous fistula(s).

FDA's Pediatric Rule at 21 CFR 314.55 and 21 CFR 601.27 was challenged in court. On October 17, 2002, the court ruled that FDA did not have the authority to issue the Pediatric Rule and barred FDA from enforcing it. Although the government decided not to pursue an appeal in the courts, it will work with Congress in an effort to enact legislation requiring pharmaceutical manufacturers to conduct appropriate pediatric clinical trials. In addition, third party interveners have decided to appeal the court's decision striking down the rule. Therefore, we encourage you to submit a pediatric plan that describes development of your product in the pediatric population where it may be used. Please be aware that whether or not this pediatric plan and subsequent submission of pediatric data will be required depends upon passage and specific requirements of legislation or the success of the third party appeal. In any event, we hope you will decide to submit a pediatric plan and conduct the appropriate pediatric studies to provide important information on the safe and effective use of this drug in the relevant pediatric populations.

We acknowledge your commitment of March 31, 2003 to submit a labeling supplement in accordance with 21 CFR 601.12(f)(1) that provides for revisions to the Patient Information Sheet by April 15, 2003.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by an FDA Form 2253.

All promotional claims must be consistent with and not contrary to approved labeling. No comparative promotional claim or claim of superiority over other products should be made unless data to support such claims are submitted to and approved by the Center for Biologics Evaluation and Research.

This information will be included in your biologics license application file.

Sincerely yours,

--- signature ---

Patricia Keegan, M.D.
Acting Director
Division of Clinical Trials Design and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research

Last Updated: 4/3/2003


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Date created: September 25, 2003

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