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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

May 28, 2003

Our STN: BL 103628/5021

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 include an HSA-free liquid formulation in a prefilled syringe as an alternate dosage form has been approved.

Results of ongoing stability studies should be submitted throughout the dating period, as they become available, including the results of stability studies from the first ------ production lots.

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FDA previously approved a Medication Guide required for distribution with this product in accordance with 21 CFR Part 208. FDA hereby approves the revised draft Medication Guide (for the prefilled syringe presentation) you submitted on May 28, 2003. Please note that:

 

  • this Medication Guide must be reprinted at the end of the package insert [21 CFR 201.57(f)(2)];

     

  • you are responsible for ensuring that this Medication Guide is available for distribution to every patient who is dispensed a prescription for this product [21 CFR 208];

     

  • the final printed Medication Guide distributed to patients must conform to all conditions described in 21 CFR 208.20, including a minimum of 10 point text; and

     

  • you are 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).

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

--- signature ---

Amy S. Rosenberg, M.D
Director
Division of Therapeutic Proteins
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research

 


Last Updated: 7/1/2003

 

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Date created: September 25, 2003

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