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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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May 21, 2004 Approval Letter

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

May 21, 2004

Our STN: BL 125062/0

OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Attention: David Hirsch, General Manager
Octapharma USA, Inc.
13800 Coppermine Road
Herndon, Virginia 20170

Dear Mr. Hirsch:

We are issuing Department of Health and Human Services U.S. License No. 1646 to OCTAPHARMA Pharmazeutika Produktionsges.m.b.H, Vienna, Austria, under the provisions of section 351(a) of the Public Health Service Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce those products for which your company has demonstrated compliance with establishment and product standards.

Under this license, you are authorized to manufacture the product Immune Globulin Intravenous (Human). Immune Globulin Intravenous (Human) is indicated for Primary Immune Deficiency (PID).

Under this license, you are approved to manufacture Immune Globulin Intravenous (Human) at your facility in Vienna, Austria. You may label your product with the proprietary name OCTAGAM and will market it in 20 mL, 50 mL, 100 mL, and 200 mL fill volumes.

The dating period for Immune Globulin Intravenous (Human) shall be 24 months from the date of manufacture when stored at 2-8 °C, or 18 months from the date of manufacture when stored at <<> 25 °C. The date of manufacture shall be defined as the date of final sterile filtration of the formulated drug product, as stated in your e-mail dated 27 February 2004. 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).

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 note that you have fulfilled 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 Immune Globulin Intravenous (Human), or in the manufacturing facilities.

We acknowledge your written commitments as described in your letters of 24 February 2004 and 28 April 2004 as outlined below:

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Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to your BLA, STN BL 125062. Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:

 

  • Postmarketing Study Protocol
  • Postmarketing Study Final Report
  • Postmarketing Study Correspondence
  • Annual Report on Postmarketing Studies

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 had them approved.

Sincerely yours,

--- signature ---

James S. Cohen, J.D.
Acting Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

--- signature ---

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