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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 |
