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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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December 9, 2003 Correction letter for October 23, 2003 Approval Letter - BabyBIG

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

December 9, 2003

Our STN: BL 125034/0

California Department of Health Services
Attention: Stephen Arnon, M.D.
c/o David Shoemaker, Ph.D.
Senior Director, Regulatory Affairs
Cato Research, Ltd.
200 Westpark Corporate Center
Durham, NC 22713-2280

Dear Dr. Arnon:

We are sending this correction letter due to an omission of a paragraph regarding adverse experience reporting. This letter replaces the letter sent to you on October 23, 2003, however, the date of issuance of your license remains unchanged.

We are issuing Department of Health and Human Services U.S. License No. 1622 to California Department of Health Services, Berkeley, California (CDHS) 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 you have demonstrated compliance with establishment and product standards.

Under this license, you are authorized to manufacture the product Botulism Immune Globulin Intravenous (Human). Botulism Immune Globulin Intravenous (Human) is indicated for treatment of infant botulism caused by type A or type B Clostridium botulinum.

Under this license, you are approved to manufacture Botulism Immune Globulin Intravenous (Human) drug substance at Massachusetts Public Health Biologic Laboratories (MPHBL) in Jamaica Plain, Massachusetts. The final formulated product will be filled and lyophilized at Cangene Corporation, Winnipeg, Manitoba, Canada. The vials will be labeled and packaged at Massachusetts Public Health Biologic Laboratories. You may label your product with the proprietary name BabyBIG and will market it in a fill volume calculated based on the IgG concentration and potency of the bulk material to achieve 100mg ± 20 mg of product.

The dating period for Botulism Immune Globulin Intravenous (Human) shall be 24 months from the date of manufacture when The dating period for Botulism Immune Globulin Intravenous (Human) shall be 24 months from the date of manufacture when stored at 2-8 oC. 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 104 days when stored at 2-8 oC.

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

We acknowledge your written commitments as described in your letter of October 23, 2003 as outlined below:

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.

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We request that you submit clinical protocols to your IND, with a cross-reference letter to this biologics license application (BLA), STN BL 125034. Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to your BLA, STN BL 125034. 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

For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for this product. The status report for each study should include:

 

  • information to identify and describe the postmarketing commitment,
  • the original schedule for the commitment,
  • the status of the commitment (i.e. pending, ongoing, delayed, terminated, or submitted), and
  • an explanation of the status including, for clinical studies, the patient accrual rate (i.e. number enrolled to date and the total planned enrollment).

As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our Web site (http://www.fda.gov/cder/pmc/default.htm). Please refer to the April 2001 Draft Guidance for Industry: Reports on the Status of Postmarketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (see http://www.fda.gov/cber/gdlns/post040401.htm) for further information.

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,

--- signature ---

Steven A. Masiello
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