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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Internal Labeling Meeting 1 - May 27, 2009 - Prevnar 13

Date:  May 27, 2009
Time:3:30-5:30 PM EST
Location:WOC-2 Conference Room 2 (with Dial-in)
File:  BLA STN: 125324
Product:Prevnar 13 [Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)]
Sponsor:Wyeth Pharmaceuticals Incorporated
Purpose:Internal Labeling Meeting #1
Participants:

Julienne Vaillancourt

Lucia Lee

Doug Pratt

Tina Khoie

Catherine Miller

Jingyee Kou

Claudia Wrzesinski

Mike Smith

Colleen Sweeney

First internal labeling meeting concerning the original draft labeling included in the BLA.  Of note, the clean-running, line-numbered, Word version of the original draft labeling, which was submitted to the BLA on April 23, 2009 (amendment seven), was used during this meeting.

Discussion focused on the following:

Review of the Highlights of Prescribing Information and Full Prescribing Information

INDICATIONS AND USAGE

  • Clarification of Guidance for Indexing Content of Labeling of SPL

DOSAGE AND ADMINISTRATION

  • Revision of sequence of language
  • Revision of the table entitled, “Vaccination Schedule for Unvaccinated Children ≥7 Months of Age.”
  • Clarification of the stated indication

DOSAGE FORMS AND STRENGTHS

  • Suggested language revisions

CONTRAINDICATIONS

  • Suggested language revision

ADVERSE EVENTS

  • Correction of reporting contact

Adjourn: 1530

Action

  1. Review team members will meet again ASAP to continue this first internal review of the original draft labeling.  An announcement for such an internal meeting will follow the present meeting.
  2. An initial set of comments on the original draft labeling will be prepared, based on discussion during these first labeling review meetings.  Comments will be internally distributed for concurrence prior to being sent to the sponsor.

Notes:

  1. This is the first internal labeling review meeting and others will follow.
  2. The pending set of initial labeling comments, will reflect the detailed  discussion, which occurred during this meeting.
 

Contact FDA

(800) 835-4709
(240) 402-8010
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Food and Drug Administration

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