Vaccines, Blood & Biologics

October 20, 1997 Approval Letter

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

October 20, 1997

Our Reference Numbers: 89-0673 and 89-0674

Gerd ZettlMeissl, M.D.
Chiron Behring GmbH & Co.
Postfach 1630
35006 Marburg

Dear Dr. ZettlMeissl:

This is to inform you of our approval of your Product License Application to manufacture and ship Rabies Vaccine into the United States for sale, barter, or exchange under U.S. License number 1222.

Under this approval you are authorized to manufacture and prepare for import and sale Rabies Vaccine for pre-exposure and post-exposure immunization of children and adults. The vaccine will be supplied as a package containing a single dose vial of lyophilized vaccine; a vial of sterile Water For Injection, USP for reconstitution; a disposable syringe; and two needles, one for reconstitution and one for injection. A single dose of the reconstituted vaccine is 1.0 mL containing at least 2.5 IU of Rabies antigen as determined by the NIH mouse potency test using the U.S. reference standard.

You are requested to submit 25 final containers of each lot for testing together with protocols showing results of all applicable tests. No lots of product shall be distributed until notification of release is received from the Director, Center for Biologics Evaluation and Research.

The dating period for this product shall be 36 months from the date of manufacture when stored at 2-8°C. The date of manufacture shall be defined as the date of initiation of the last valid potency test.

The Supplement to your Establishment License Application (Ref. No. 89-0673) to include the areas and equipment used for the manufacture of Rabies Vaccine has also been approved.

We acknowledge your commitment to provide a copy of the standard operating procedure [#######################(b)(4)#########################]as soon as the revision has been completed.

Changes in the manufacture, testing, packaging or labeling of Rabies Vaccine or in the manufacturing facilities should be reported in accordance with the provisions of 21 CFR 601.12, Changes to an Approved Application, published in the Federal Register on July 24, 1997.

It is requested that adverse experience reports for Rabies Vaccine 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). Since your product is categorized as a vaccine, these reports should be submitted to the Vaccine Adverse Event Reporting System (VAERS) using the pre-addressed form VAERS-1.

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.

Please acknowledge receipt of the enclosed product license to the Director, Division of Vaccines and Related Products Applications, HFM-475, Center for Biologics Evaluation and Research.

Sincerely yours,

 --- signature ---

M. Carolyn Hardegree, M.D.
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research


--- signature ---

Jerome A. Donlon, M.D., Ph.D.
Office of Establishment Licensing and Product Surveillance
Center for Biologics Evaluation and Research

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