Revision Bulletin

Ondansetron Tablets

In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, the Biopharmaceutics Expert Committee has revised the Ondansetron Tablets monograph to include a Dissolution Test 2 due to FDA’s approval of a generic product with different Tolerances; and a Dissolution Test 3 due to the U.S. Food and Drug Administration’s approval of another generic product with different dissolution conditions.

The Ondansetron Revision Bulletin supersedes the monograph in USP 32-NF 27 until it is printed in the USP 33–NF 28 First Supplement which will be released 1 February 2010 and becomes official 1 August 2010.

Should you have any questions, please contact Margareth Marques, Ph.D., (301–816–8106 or .

Download the Ondansetron Tablets Revision Bulletin  (147KB)