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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Labeling Review: TachoSil Full Prescribing Information BLA STN: 125351/0/008 - TachoSil, March 25, 2010

 

 

 

MEMORANDUM

Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

Date:March 25, 2010
From:Jean Makie, M.S., R.D., Acting Branch Chief
Advertising and Promotional Labeling Branch (APLB) (HFM-602)
Division of Case Management (DCM)
To:Jie He, RPM, OBRR, DBA, RPMB (HFM-380)
Natalya Ananyeva, Ph.D., CMC Committee Chair, OBRR, DH, LBVB (HFM-343)
Kimberly Lindsey, M.D., Medical Officer, OBBR, DH, CRB (HFM-392)
Subject:Labeling Review: TachoSil Full Prescribing Information
BLA STN: 125351/0/008

Background: On February 5, 1010, Nycomed submitted the first revised prescribing information (PI) to BLA 125351, ---------------------------(b)(4)-----------------------------      ----------------------------------- for TachoSil and to pursue approval only for the indication related to hemostasis in cardiovascular surgery.  

Executive Summary: OBRR consulted with APLB to review the proposed PI. As a result, the assigned medical officer and APLB reviewer cooperatively reviewed and revised the proposed PI submitted by Nycomed on February 5, 2010. APLB offered comments and recommendations from a promotional and comprehension perspective.

On March 5, 2010, OBBR sent an annotated PI as an Information Request (IR) to Nycomed. In response, on March 10, 2010, Nycomed submitted a revised proposed PI. APLB and the medical officer reviewed this submission, and also incorporated comments from other Review Committee members. An annotated PI was sent to Nycomed on March 12, 2010. Nycomed responded to this IR by submitting a revised draft PI on March 17, 2010.

APLB offered comments and recommendations from a promotional and comprehension perspective on each of these draft labels, and has worked closely with the Medical Officer to resolve labeling issues. Working with the Medical Officer’s most recent version of the PI (circulated to the team for further discussion on March 23, 2010), APLB has included its comments and recommendations to OBBR for further consideration from a promotional and comprehension perspective.

Attachments: Full Prescribing Information, TachoSil