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 Product Approval Information - Licensing Action

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

November 6, 1997

Our Reference No: 96-0958

Tobias Massa, Ph.D.
Schering Corporation
Galloping Hill Road
Kenilworth, NJ. 07033

Dear Dr. Massa:

Your request to supplement your biologics license application for Interferon alfa-2b to include a new indication for use of INTRON A in conjunction with chemotherapy in patients with follicular lymphoma has been approved.

Please submit three copies of final printed labeling at the time of use and include part II of the label transmittal form with completed implementation information. Final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by an FDA Form 2567. 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 ---

Karen D. Weiss, M.D.
Director
Division of Clinical Trial Design and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research

 


Last Updated: 1/19/2001

 

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Date created: September 25, 2003

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