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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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December 15, 2003 Approval - Flebogamma DIF 5%

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

December 15, 2003

Our STN: BL 125077/0

Instituto Grifols, S.A.
Attention: Mr. Howard Smith
Sr Director, Reg Operations/Medical Writing
675 Peter Jefferson Parkway, Suite 120
Charlottesville, VA 22911-5801

Dear Mr. Smith:

We have approved your biologics license application for Immune Globulin Intravenous (Human) effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Immune Globulin Intravenous (Human) under your existing Department of Health and Human Services U.S. License No. 1181. Immune Globulin Intravenous (Human) is indicated for replacement therapy in primary (inherited) humoral immune deficiency disorders.

Under this authorization, you are approved to manufacture Immune Globulin Intravenous (Human) at your facility in Barcelona, Spain. You may label your product with the proprietary name Flebogamma 5% and market it in 10, 50, 100, and 200 mL fill sizes.

The dating period for Immune Globulin Intravenous (Human) shall be 24 months from the date of manufacture when stored at 2-25°C. The date of manufacture shall be defined as the date of final sterile filtration of the formulated drug product. The dating period for your drug substance shall be ------- when stored at ------°C.

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).

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 Immune Globulin Intravenous (Human), or in the manufacturing facilities.

We acknowledge your written commitments as described in your letter of December 1, 2003 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 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 have 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

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(240) 402-8010
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Food and Drug Administration

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