7/12/2017
`
`CBER, Approval letter, for Infliximab, new indication for reduction in signs and symptoms of rheumatoid arthritis, Centocor, Inc.
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`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`Public Health Service
`Food and Drug Administration
`1401 Rockville Pike
`Rockville, MD 20852-1448
`
`November 10, 1999
`
`Our Reference No.: 99-0128
`
`Mr. Martin Page
`Centocor, Inc.
`200 Great Valley Parkway
`Malvern, PA 19355
`
`Dear Mr. Page:
`
`Your request to supplement your biologics license application for Infliximab to include a new
`indication for reduction in signs and symptoms of rheumatoid arthritis in patients who have had an
`inadequate response to methotrexate has been approved.
`
`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 FR66632). [----------------------------------------------------------------------------------------------------
`-------------------------------------].
`
`We acknowledge your written commitments of July 9, 1999, September 8, 1999, and November 4,
`1999, which include the following:
`
`1. To develop an assay to measure rheumatoid factor reactivity to Infliximab (IFX-RF) and
`perform the analysis on serum samples from patients in the ATTRACT study. We note that
`development of this assay has commenced and that results will be submitted by June 2000.
`
`2. To continue a three-year, long-term safety follow-up and provide the information to the
`Center on a periodic basis, at least annually. This commitment includes obtaining long-term
`safety information on malignancies, deaths, autoimmune disorders and delayed
`
`https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/inflcen111099L.htm
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`7/12/2017
`
`CBER, Approval letter, for Infliximab, new indication for reduction in signs and symptoms of rheumatoid arthritis, Centocor, Inc.
`hypersensitivity for three years and serious infections for six months after patients have
`received their last infusion of Infliximab. If additional safety concerns are identified after this
`period, the Center may, in consultation with Centocor, require an extension and/or
`modification of the safety follow-up.
`
`3. To conduct a juvenile rheumatoid arthritis clinical study. [-------------------- ---------------------
`--------------------------------------------------------------
`-----------------------------------------------------------------------------------
`------------------].
`
`4. To submit a proposal by June 2000 as to how Centocor will evaluate the response to
`immunizations in Infliximab-treated patients.
`
`5. To demonstrate that the relative reactivity of the [--------------------] as defined by reactivity
`with BSA-deficient media, is proportional to the [----] content in a non-secreting, transfected
`cell line cultured in the same medium.
`
`6. To perform spiking studies to validate the ability of the Infliximab purification process to
`remove [------] and to continue testing individual lots of [----------] until these validation
`studies are completed.
`
`7. To develop an assay to measure serum antibodies to bovine IgG which will be used to assay
`serum samples from patients who participated in Centocor’s C0168T24 trial. The assay will
`be developed by July 2000 and results from the T24 samples will be submitted by August
`2000.
`
`Please submit three copies of final printed labeling at the time of use and include part II of the label
`transmittal form (FDA form 2567) with completed implementation information. In addition, you
`may wish to submit draft copies of the proposed introductory advertising and promotional labeling
`with an FDA Form 2567 or Form 2253 to the Center for Biologics Evaluation and Research,
`Advertising and Promotional Labeling Staff, HFM-202, 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 2567 or 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 biologic license application file.
`
`Sincerely yours,
`
`--- signature ---
`
`Karen D. Weis, M.D.
`Director
`Division of Clinical Trial Design and Analysis
`Office of Therapeutics Research and Review
`Center for Biologics Evaluation and Research
`
`Last Updated: 1/12/2001
`
`
`https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/inflcen111099L.htm
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`7/12/2017
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`CBER, Approval letter, for Infliximab, new indication for reduction in signs and symptoms of rheumatoid arthritis, Centocor, Inc.
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