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Mitotane Tablets

Type of Posting: Notice of Intent to Revise
Posting Date: 21-Apr-2022
Targeted Official Date: 1-Aug-2023; Revision Bulletin
Expert Committee: Small Molecules 3

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 3 Expert Committee intends to revise the official date from August 1, 2022 to August 1, 2023 for the recently approved and published changes to the Mitotane Tablets monograph. Comments were received that indicate additional time is needed for manufacturer compliance.

It is anticipated that the proposed revision to the official date will be published on June 24, 2022 as a Revision Bulletin pursuant to the Rules and Procedures. 

Should you have any questions, please contact Robyn Fales, Senior Scientist I (