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February 12, 2004 Approval Letter - Rhophylac

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville MD 20852-­1448

February 12, 2004

Our STN: BL 125070/0

ZLB Bioplasma AG
Attention: Richard Peck, Ph.D.
Head, Regulatory Affairs
Wankdorfstrasse 10
Postfach, 3000
Bern 22, Switzerland

Dear Dr. Peck:

We have approved your Biologics License Application for Rho(D) Immune Globulin Intravenous (Human) effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Rho(D) Immune Globulin Intravenous (Human) under your existing Department of Health and Human Services U.S. License No. 1598. Rho(D) Immune Globulin Intravenous (Human) is indicated for routine antepartum and postpartum prevention of Rho(D) immunization in Rho(D)-negative women, for Rhesus prophylaxis in case of obstetric complications, for Rhesus prophylaxis in case of invasive procedures during pregnancy, and for the suppression of Rhesus immunization in Rho(D)-negative individuals transfused with Rho(D)-positive red blood cells (RBCs) or blood components containing Rho(D)-positive RBCs.

Under this license, you are approved to manufacture Rho(D) Immune Globulin Intravenous (Human) at ZLB Bioplasma AG in Bern, Switzerland. The final formulated product will be filled, labeled, and packaged at -------------------------------------------------------------------. You may label your product with the proprietary name Rhophylac and will market it in pre-filled syringes for either intravenous or intramuscular injection. Each syringe must contain at least 1500 IU (300 mg) of Rho(D) Immune Globulin (Human) in a 2 mL solution.

The dating period for Rho(D) Immune Globulin Intravenous (Human) shall be 36 months from the date of manufacture when stored at 2-8 °C. The date of manufacture shall be defined as the date of the first sterile filtration of the formulated drug product.

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).

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 are waiving the pediatric study requirement 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 Rho(D) Immune Globulin Intravenous (Human) or in the manufacturing facilities.

We acknowledge your written commitments as described in your letters of October 17, 2003, October 21, 2003, November 17, 2003, December 8, 2003, January 14, 2004, January 26, 2004, and February 9, 2004, as outlined below:

Postmarketing commitments 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 should promptly 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 a 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 ---

Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Silver Spring, MD 20993-0002