• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

March 30, 2007 Approval Letter

Our STN: BL 125234/0

Baxter Healthcare Corporation
Attention: Dr. Stephen Gracon
One Baxter Way
Westlake Village, CA 91362

Dear Dr. Gracon:

We have approved your biologics license application for Protein C Concentrate (Human) effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Protein C Concentrate (Human) under your existing Department of Health and Human Services U.S. License No. 140. Protein C Concentrate (Human) is indicated for patients with Severe Congenital Protein C Deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.

Under this license, you are approved to manufacture Protein C Concentrate (Human) drug substance at --------------------------------------------------. The final formulated product will be manufactured, filled, labeled, and packaged at --------------------------------------------. You may label your product with the proprietary name CEPROTIN and will market it in 500 IU/vial and 1000 IU/vial sizes.

The dating period for Protein C Concentrate (Human) shall be 36 months from the date of manufacture when stored at 2oC to 8oC. 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 your drug substance shall be --- months when stored at ------.

Please submit final container samples of the product in final containers 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 Biologic Evaluation and Research (CBER).

Your request for an exemption to the general safety test (GST) on final product is granted.

Your request for a waiver to the required reporting format for postmarketing periodic safety reports under 21 CFR 600.80 is granted. You may submit these reports using the Periodic Safety Update Report (PSUR) format as described in the ICH E2C guidance.

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 Protein C Concentrate (Human), or in the manufacturing facilities.

We acknowledge your written commitments as described in your letter of March 21, 2007 as outlined below:

  1. ----------------------------------------------------------------------------------------------
    ------------------------------------------------------------------------------
    ------------------------------------------
  2. ---------------------------------------------------------------------
    ----------------------------------------------------------
    ----------------------------------------------------------------
    --------------------------------------------------------
    -----------------------------------------------------------------

In addition, pursuant to 21 CFR 600.80(c)(2)(Periodic Adverse Experience Reports), the Agency is requiring that manufacturers report on a monthly basis any infectious disease transmission associated or possibly associated with any licensed biological product that is not reportable under 21 CFR 600.80 (c)(1)(Fifteen-day Alert Reports). The timing of this monthly periodic reporting requirement was selected, among other reasons, to permit the acquisition of patient information, including clinical evaluation, sufficient to help in the timely assessment of a causal connection between the biological product and possible or documented infectious disease transmission. This new reporting requirement was also based on the observation of inconsistent practices by some manufacturers in submitting reports of possible infectious diseases.

Please note that this monthly reporting requirement applies only to infectious disease transmission. Other periodic reports should continue to be submitted on the quarterly or annual basis that is appropriate to each licensed biological product for all other adverse experiences not reportable under 21 CFR 600.80(c)(1). You should submit these monthly reports to the Center for Biologics Evaluation and Research, Division of Epidemiology, HFM-210, 1401 Rockville Pike, Rockville, MD, 20852-1448. Please contact the Division of Epidemiology (301-827-3974) if you have any questions about these periodic adverse event reporting requirements.

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. 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,

--- signature ---

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