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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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March 21, 2008 Approval Letter- ARTISS

Our STN: BL 125266/0

Baxter Healthcare Corporation
Attention: Mr. Brian L. Bishop
One Baxter Way
Westlake Village, CA 91362-3811

Dear Mr. Bishop:

This letter corrects our letter dated March 19, 2008. The information regarding the storage and use for the lyophilized and frozen presentations of this product is revised to be consistent with your approved package insert. Your approval date remains March 19, 2008.

We have approved your biologics license application for Fibrin Sealant (Human) effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Fibrin Sealant (Human) under your existing Department of Health and Human Services U.S. License No. 140. Fibrin Sealant (Human) is indicated for adhering autologous skin grafts to surgically prepared wound beds resulting from burns in adults and pediatric populations.

Under this license, you are approved to manufacture Fibrin Sealant (Human) drug substance at Baxter Healthcare Corporation in --------------------. The final formulated product will be manufactured, filled, labeled, and packaged at Baxter Healthcare Corporation, -----------------
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------------------------------------------------------------------------------------- You may label your product with the proprietary name ARTISS and will market it in 2, 4, and 10 ml sizes in two dosage forms, frozen and lyophilized (kit).

The dating period for Sealer Protein /Aprotinin and for the Thrombin in the frozen presentation shall be 24 months from the date of manufacture when stored at or below -20oC. Product in unopened pouches, thawed at room temperature, may be stored for up to 7 days at 15-25oC. Following quick thawing, product must be used within 12 hours after warming to 33-37oC.

The dating period for Sealer Protein Concentrate and for the Thrombin in the lyophilized (kit) presentation shall be 24 months from the date of manufacture when stored at 2oC to 25oC. Following reconstitution the product must be used within 4 hours. The dating period for the Calcium Chloride for the kit shall be 36 months from the date of manufacture when stored at room temperature. The dating period for the Aprotinin Solution for the kit shall be 24 months from the date of manufacture when stored at or below 25oC.

The date of manufacture shall be defined as the date of final sterile filtration of the formulated drug product. Following the final sterile filtration, no reprocessing/reworking is allowed without prior approval from the Agency. The dating period for Sealer Protein drug substance shall be -- months when stored at or below -----, or -- days when stored at room temperature. The dating period for Thrombin drug substance shall be -- months when stored at or below --------, or up to -- days when stored at ------. The expiration date for the packaged product, whether in the kit or frozen presentation, shall be dependent on the shortest expiration date of any component.

Please submit final container samples of the product together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).

All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We have reviewed your submission and agree that a partial waiver of your pediatric studies for Fibrin Sealant for ages 0-1 year is justified because of too few children with the condition to study. We note that you have fulfilled the pediatric study requirement for ages 1 -16 years for this application.

You must submit information to your biologics license application for our review and written approval under 21 CFR 601.12 for any changes in the manufacturing, testing, packaging or labeling of Fibrin Sealant, or in the manufacturing facilities.

We acknowledge your written commitments as described in your letter of March 10, 2008 as outlined below:

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70

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You must submit adverse experience reports under the adverse experience reporting requirements for licensed biological products (21 CFR 600.80) and you must submit distribution reports under 21 CFR 600.81. You should submit postmarketing adverse experience reports and distribution reports to the Center for Biologics Evaluation and Research, HFM-210, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Prominently identify all adverse experience reports as described in 21 CFR 600.80.

You must submit reports of biological product deviations under 21 CFR 600.14. You promptly should identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Two copies of final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by FDA Form 2253.

All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have submitted data to support such claims to us and had them approved.

Sincerely yours,

/Jay S. Epstein, M.D./
Jay S. Epstein, M.D.
Director
Office of Blood Research and Review
Center for Biologics Evaluation and Research