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 Product Approval Information - Licensing Action

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

May 12, 1998

Our Reference Number: 97- 1251

John R. Cutt, Ph.D.
Novartis Pharmaceutical Corporation
59 Route 10
East Hanover, NJ 07936-1080

Dear Dr. Cutt:

This letter hereby issues Department of Health and Human Services Biologics License No. 1244 to Novartis Pharmaceutical Corporation, East Hanover, New Jersey, in accordance with the provisions of Section 351 (a) of the Public Health Service Act, as amended November 21, 1997 (FDAMA; Public Law 105-l15), controlling the manufacture and sale of biological products. This license authorizes you to manufacture and ship for sale, barter, or exchange, in interstate and foreign commerce, those products for which your company has demonstratedcompliance with establishment and product standards.

Under this license you are authorized to manufacture and ship the product Basiliximab. Basiliximab is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

Under this authorization, you are approved to manufacture Basiliximab at your facility in Basel, Switzerland. Final formulated drug product will be filled at Base1 and unlabeled vials of drug product will be shipped to the East Hanover, New Jersey facility for labeling, packaging and distribution. In accordance with approved labeling, your product will bear the trade name Simulect, and will be marketed in single-use glass vials containing 20 mg of Basiliximab.

You are not currently required to submit samples of future lots of Basiliximab 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 Basiliximab shall be 18 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 final formulated product. The drug substance may be stored for up to 6 months at below -60°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.

Any changes in the manufacturing, testing, packaging or labeling of Basiliximab, 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.

We acknowledge the written commitments specified in your letters dated May 8, 1998 which include the following:

  1. To submit final study reports on the long-term follow-up for protocols ______________________ by December 2001.

  2. To submit, with due diligence, the final study reports on all ongoing protocols submitted to ____________ upon completion of the trials.

  3. To design and conduct a study to examine immunological tolerance during and after treatment with Basiliximab. The study will be conducted, with due diligence, upon agreement of a study design by Novartis and the FDA.

  4. To submit the protocols and summary data for the column reuse studies and bacteriostatic effectiveness of the column storage solutions by December 1998.

  5. To submit temperature monitoring data for the first three commercial shipments of filled unlabeled drug product from Basel, Switzerland to East Hanover, New Jersey as they become available.

  6. To submit the shipping validation protocol for Basiliximab by December 1998.

  7. To include routine temperature monitoring during final product shipments until shipping validation and product stability studies are completed.

  8. To submit the testing protocol and the final report for hepatitis C virus testing of the MCB by September 30, 1998.

  9. We also acknowledge additional information in your letter of May 8, 1998 addressing the agency’s observations noted during the March 10-20, 1998 prelicense inspection and your commitment to submit additional information and data within the timelines specified.

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). All adverse experience reports should be prominently identified according to 21 CFR 600.80 and be submitted to the 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 (FDA Form 2567) 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 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 biologics license to the Director, Division of Application Review and Policy (HFM-585), Center for Biologics Evaluation and Research.

Sincerely yours,

--- signature ---

Jay P. Seigel, M.D., FACP
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research

Last Updated: 1/18/2001


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Date created: September 25, 2003

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