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Product Approval
Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
November 26, 1997
Our Reference No.: 97-0260
Alice Wei
Director, Regulatory Affairs
IDEC Pharmaceuticals Corporation
11011 Torreyana Road
San Diego, CA 92121
Dear Ms. Wei:
This letter hereby issues Department of Health and Human Services Biologics License No. 1235 to IDEC Pharmaceuticals Corporation, San Diego, California, in accordance with the provisions of Title III Part F of the Public Health Service Act of July 1, 1944 (58 Stat. 702) 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 demonstrated compliance with establishment and product standards.
Under this license you are authorized to manufacture and ship for sale the product Rituximab Formulated Bulk (For Further Manufacturing Use). Under this authorization, you are approved to manufacture Rituximab Formulated Bulk at your facility in San Diego, California for use in the manufacture of Rituximab by Genentech, Inc., under a shared manufacturing arrangement. Final containers of Rituximab will be filled, labeled, packaged and distributed under the tradename RITUXAN by Genentech, Inc. at their facility in South San Francisco, California.
You are not currently required to submit samples of future lots of Rituximab Formulated Bulk 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 Rituximab Formulated Bulk shall be 60 days 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 the formulated bulk. 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 Rituximab Formulated Bulk, 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. Any such changes which may affect the safety, purity and potency of the product should also be reported simultaneously to Genentech, Inc., the manufacturer of the drug product.
We acknowledge your written manufacturing commitments of November 18, 1997, to:
- Revise production batch records and conduct assessments to minimize variances.
- Improve production oversight by increasing the number of personnel in Manufacturing and Quality areas.
We also acknowledge your written clinical commitments of November 25, 1997, to:
- Submit the final study report, including case report form tabulations for Protocol 102-08R, the study of Rituximab retreatment, within 12 months of enrolling the last patient. Data which are not mature (e.g., response duration or outcome resolution for CD19+ depletion or immunoglobulin levels, pharmacokinetic data at six or nine months) will be supplied when mature.
- Submit the final study report, including case report form tabulations for Protocol 102-O8B, the study of Rituximab treatment in patients with bulky disease (>lO cm in largest diameter) within 12 months of enrolling the last patient. Data which are not mature (e.g., response duration or outcome resolution for CD19+ depletion or immunoglobulin levels, pharmacokinetic data at six or nine months) will be supplied when mature.
- Submit the final study report, including case report form tabulations for Protocol 102-09, entitled "Pilot Study to Compare and Evaluate the Safety and Impact of IDEC-C2B8 on Immunization Potential" within 12 months of enrolling the last patient. Additionally, the following amendments to the protocol will be submitted within 60 days:
- timepoints prior to six months after the second immunization will be added for all study arms for patients who have not reached six months;
- the analytic section will be revised to clarify both the primary efficacy analysis and how missing data points in the primary efficacy analysis (for patients who exit early due to disease progression) will be handled; and
- immunization with an antigen to which the study population is immunologically naive will be included, in order to evaluate the effect of prior Rituximab therapy on a primary immune response.
- Submit, within 60 days, a protocol for evaluation of the effect of Rituximab therapy on the levels of preexisting serum titers against viral and/or bacterial antigens. In support of this protocol, data from two control groups from Protocol 102-09 which address the range of serologic titers at study entry and the number of patients needed to show whether clinically relevant change occurs in the months following Rituximab administration, will be submitted.
It is acknowledged that Genentech, Inc. will receive adverse experience reports and be responsible for submitting those reports to FDA in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80) as well as distribution reports as described (21 CFR 600.81).
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. Siegel, M.D., FACP
Director
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
Last Updated: 1/15/2001
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Date created: September 25, 2003 |
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