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

October 6, 1997

Our Reference No.: 96-0486 and 97-0106

N. Kirby Alton, Ph.D.
Amgen, Inc.
1840 DeHavilland Drive
Thousand Oaks, CA 9 1320- 1789

Dear Dr. Alton:

Your biologics license application for Interferon alfacon-1 is approved effective this date. Amgen, Inc., Thousand Oaks, California is hereby authorized to manufacture and ship for sale, barter, or exchange in interstate and foreign commerce Interferon alfacon-1 under Department of Health and Human Services Biologics License No. 1080.

Interferon alfacon-1 is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA.

Also at this time, we are approving your supplemental application (97-0106) to include subsequent treatment of HCV infected patients who have tolerated an initial course of interferon therapy with 15ug of Interferon alfacon-1 for 24 weeks.

In accordance with approved labeling, your product will bear the tradename Infergen, and will be marketed in single-use vials containing either 9 ug or 15 ug Interferon alfacon-1 .

You are not currently required to submit samples of future lots of Interferon alfacon-1 to the Center for Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR 610.2. FDA will continue to monitor compliance with 21 CFR 610.1 requiring assay and release of only those lots that meet release specifications.

The dating period for this product shall be 24 months from the date of manufacture when stored at 2-8°C The date of manufacture shall be defined as the date of final sterile filtration of the formulated product. The purified bulk Interferon alfacon-1 may be stored for up to 6 months at 2-8°C. 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 three production lots.

We acknowledge your letter of October 1, 1997 in which you commit to conduct a randomized, multicenter, controlled study to assess the safety and efficacy of Interferon alfacon-1 in 175 interferon-naive patients treated for six months versus 175 interferon-naive patients treated for 18 months.

We also acknowledge your written commitments of February 28, 1997 to provide the following:

 

1. A validation report for, and stability data from, the revised method for the reversed phase HPLC assay. Validation will include data on the sensitivity, reproducibility, and precision of quantification of minor peaks (i.e. oxidized and other forms).

 

2. A validation report for the effects of erythropoietin (EPO) concentration and cell passage on the antiproliferative bioassay, as well as details on the management of EPO stocks used in this assay.

 

3. A validation report for the revised peptide mapping procedure using [----------] digestion of reduced, carboxymethylated interferon alfacon-1.

 

4. A validation report for the isoelectric focusing procedure used in stability testing of Interferon alfacon-1.

 

5. A revised [-------] for the [------------------------------] [-----------] and a certificate of analysis for the secondary reference standard currently in use for interferon bioassays.

 

6. In addition, you will continue to monitor trends in changes of the relative levels of amino-terminal variants and the correlation of these changes with all measured fermentation parameters. We recommend that alert limits be established for these variants to signal exceptional changes in the fermentation process.

Any changes in the manufacture, packaging or labeling of the product or in the manufacturing facilities will require the submission of information to your biologics license application for our review and written approval consistent with 21 CFR 601.12.

It is requested that adverse experience reports be submitted in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80) and that distribution reports be submitted as described (21 CFR 600.81). These requirements became effective on December 27, 1994. All experience reports should be prominently labeled according to 21 CFR 600.80 and be submitted to Center for Biologics Evaluation and Research, HFM-210, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.

Please submit three copies of all final printed labeling at the time of use and include part II of the label transmittal form with completed implementation information. In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2567 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Staff, HFM-202, 1401 Rockville Pike, Rockville, MD 20852-1448. 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 similar products should be made unless data to support such claims are submitted to and approved by the Center for Biologics Evaluation and Research.

Sincerely yours,

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Date created: September 25, 2003

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