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Issue Number 17                                           August 31, 1998

CONTENTS OF THIS ISSUE

1. ROTAVIRUS VACCINE LICENSE APPLICATION IS APPROVED BY FDA
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(1)
August 31, 1998
ROTAVIRUS VACCINE LICENSE APPLICATION IS APPROVED BY FDA

On August 31, 1998, the FDA approved a license application for rotavirus vaccine, live, oral, tetravalent.  RotaShield is the trade name of this vaccine. RotaShield is indicated for the prevention of gastroenteritis caused by those rotavirus serotypes contained in the vaccine. The recommended dosing schedule for oral immunization with RotaShield is 2, 4, and 6 months of age. Initiation of vaccination after 6 months of age is currently not recommended.

RotaShield is manufactured by Wyeth Laboratories, Inc. of Marietta, Pennsylvania, and distributed by Wyeth-Lederle Vaccines and Pediatrics. Please see the package insert for additional information.

 

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This page was updated on September 1, 1998