Product Approval
Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
November 4, 2002
Our STN: BL 103663/5011
InterMune, Incorporated
Attention: Marianne Armstrong
Senior Vice President, Global Regulatory
Operations and Corporate Compliance
3280 Bayshore Boulevard
Brisbane, CA 94005
Dear Ms. Armstrong:
Your request to supplement your biologics license application for
Interferon alfacon-1, to provide a medication guide, has been
approved.
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 alfacon-1 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 November 4, 2002. 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).
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: 2/21/2003
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Date created: September 25, 2003 |