March 17, 1995 Approval Letter - Varivax
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
March 17, 1995
Our Reference No.: 93-0395 and 93-0440
Barry D. Garfinkle, Ph.D.
Merck and Co., Inc.
West Point, PA 19486-0004
Dear Dr. Garfinkle:
Enclosed is a product license authorizing Merck and Co., Inc., U.S. License No. 2, to manufacture and ship Varicella Virus Vaccine Live, in the United States for sale, barter, or exchange.
Under this license you are authorized to manufacture and prepare for sale, Varicella Virus Vaccine Live for the active immunization of persons 12 months of age and older. The vaccine will be presented in 0.5 mL single dose vials containing a minimum of 1350 plaque forming units of Varicella Virus Vaccine Live 30 minutes after reconstitution.
You are requested to submit a sample of the bulk and samples of product in final containers 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 (CBER).
The dating period for this product shall be 42 months from the date of manufacture when stored at -15 to -20°C. The filled container may be stored for up to 24 months at -20°C or colder prior to packaging. After packaging the market dating is 18 months at -15°C. The date of manufacture shall be defined as the date of the last valid potency test.
The Supplement to your Establishment License Application (Ref. No. 92-0440) to include the areas and equipment used for the manufacture of Varicella Virus Vaccine Live, has also been approved.
Any changes in the manufacture, testing, packaging or labeling of Varicella Virus Vaccine Live or in the manufacturing facilities will require the submission of a Supplement to either your Product or Establishment License Application for our review and written approval prior to implementation.
Your commitment to perform post-licensure studies over at least a 15 year period, following the outline in your submission to the Product License Application dated August 19, 1994, with modifications specified in submissions of February 24, 1995, and March 10, 1995 is acknowledged to be an integral part of the basis for approval. It is understood that Merck will provide CBER with copies of the appropriate protocols, and CBER will have the opportunity to comment on these protocols prior to initiation of any studies. It is further understood that Merck will provide CBER with annual reports on the progress of these studies. These commitments have been made a part of your Product License Application for this product.
It is requested that adverse experience reports for Varicella Virus Vaccine Live 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, it is our recommendation that these reports be submitted to the Vaccine Adverse Event Reporting System (VAERS) using the pre-addressed form VAERS-1. The toll-free number for VAERS forms and information is 800-822-7967.
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. In addition, advertising and promotional labeling should be submitted for review and approval prior to the initial publication of any advertisement and prior to the initial dissemination of any promotional labeling for the first 120 days following approval. 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.
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.
M. Carolyn Hardegree, M.D. /s/ Jerome A. Donlon, M.D., Ph.D.
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Office of Establishment Licensing and
Center for Biologics Evaluation and Research
M. Carolyn Hardegree, M.D.
Jerome A. Donlon, M.D., Ph.D.