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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, September 21, 2012 - EVARREST

RECORD OF TELEPHONE CONVERSATION

Submission Type:BLA    Submission ID:STN 125392    Office: OBRR

Title/Product:

EVARREST, FIBRIN SEALANT PATCH

Sponsor/Applicant:

ETHICON

Telecon Date/Time: 21-Sep-2012 4:30 PM        Initiated by FDA? Yes

Telephone Number: --b(4)----------------

Communication Categorie(s):

1. INFORMATION REQUEST (IR)

Author: KIMBERLY LINDSEY

Telecon Summary:

CLINICAL INFORMATION REQUEST

FDA Participants:

KIMBERLY LINDSEY

TRACY TILGHMAN

Non-FDA Participants:

JESSICA CHUNG

Referenced Amendment(s):

Telecon Body:

FDA had a telecon with the sponsor and requested the following information:

Please provide the event rates for the adverse reactions listed in Table 1, section 6 (Adverse Reactions) of the EVARREST package insert draft. Specifically, FDA requested that Ethicon provide the total number of events in each treatment group for  each adverse reaction term. FDA noted that the information preceding the table does not adequately explain the dataset from which the Adverse Reaction table was derived. FDA requested that this information be sent as soon as possible (preferably before Monday September 24, 2012). Ethicon committed to provide the information as requested.