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Product Approval
Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
January 31, 2003
Our STN: BL 103628/5001
Nadine D. Cohen, Ph.D.
Biogen, Incorporated
14 Cambridge Center
Cambridge, MA 02142
Dear Dr. Cohen:
Your request to supplement your biologics license application for Interferon beta-1a, to revise the package insert to include safety and efficacy data from a study of patients who experienced a single clinical exacerbation of multiple sclerosis and to provide a Medication Guide has been approved.
We acknowledge your commitment to provide additional information and to conduct a postmarketing study as described in your letters of January 29 and 30, 2003, and as outlined below:
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To issue a letter to healthcare providers, in accordance with 21 CFR 200.5, informing them of the updated safety information added to the Interferon beta-1a package insert. A final draft of the letter will be submitted to CBER by February 5, 2003, and disseminated by March 16, 2003.
- To conduct a pregnancy registry study to prospectively record and analyze pregnancy outcomes in 300 pregnant women with multiple sclerosis exposed to Interferon beta-1a at the time of conception or during the first trimester of pregnancy. This information will be used to assess the potential risk to the mother, fetus and/or live born infant. The final protocol will be submitted to CBER by June 30, 2003. Patient accrual will be completed by December 31, 2007, the study will be completed by
December 31, 2008, and a final study report submitted by July 31, 2009.
Pursuant to 21 CFR Part 208, FDA has determined that this product poses a serious and significant public health concern requiring the distribution of a Medication Guide. Interferon beta-1a is a product for which patient labeling could help prevent serious adverse effects and inform the patient of serious risks relative to benefit that could affect their decisions to use, or continue to use, the product. Therefore, a Medication Guide is necessary for safe and effective use of this product and FDA hereby approves the draft Medication Guide you submitted January 30, 2003. Please note that the final printed Medication Guide must conform to all conditions described in 21 CFR 208.20, including a minimum of 10 point text.
Additionally, in accordance with 21 CFR 208, you are responsible for ensuring that this Medication Guide is available for distribution to every patient who is dispensed a prescription for this product. You are also responsible for ensuring that the label of each container or package includes a prominent and conspicuous instruction to authorized dispensers to provide a Medication Guide to each patient to whom the drug is dispensed, and states how the Medication Guide is provided.
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).
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: 2/5/2003
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Date created: September 25, 2003 |
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