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Revision Bulletin

Leflunomide Tablets

Posting Date: 29 September 2009
Official Date: 1 November 2009
Expert Committee: Biopharmaceutics


In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, the Biopharmaceutics Expert Committee has revised the Leflunomide Tablets monograph by the inclusion of a Dissolution Test for a new product approved by the Food and Drug Administration.

Leflunomide Tablets 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 Leflunomide Tablets Revision Bulletin  (112KB).