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March 31, 2005 Approval Letter - WinRho SDF Liquid

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

March 31, 2005

Our STN: BL 103649/5107

Cangene Corporation
Attn: Steve McGregor
Director, Regulatory Affairs
3403 American Drive
Mississauga, Ontario, Canada
L4V 1T4

Dear Mr. McGregor:

Your submission to supplement your Biologics License Application for the manufacture of Rho(D) Immune Globulin Intravenous (Human) (WinRho SDF Liquid), dated June 9, 2004, to allow a liquid formulation, has been approved.

We acknowledge your written commitments as described in your letters of March 14, 23 and 30, 2005 outlined below:

 

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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.

This information has been placed in your biologics license file. It is recommended that a copy of this letter be available for review at the time of FDA inspections.

Sincerely yours,

--- signature ---

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

 

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