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Notice of Intent to Revise: Baclofen Injection

Type of Posting: Notice of Intent to Revise
Posting Date: 30-Apr-2021
Targeted Official Date: 01-Jul-2021; Revision Bulletin
Expert Committee: Small Molecules 4

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 4 Expert Committee intends to revise the Baclofen Injection monograph.

Comments with supporting data were received that indicate the pH acceptance criteria of 5.5-6.8 may not be applicable to all approved products. The Expert Committee proposes to revise the pH acceptance criteria from 5.5-6.8 to 5.0-7.5 to accommodate FDA-approved drug products with different limits.

It is anticipated that the proposed revision will be published as a Revision Bulletin on June 25, 2021 with an anticipated official date of July 1, 2021.

Should you have any questions, please contact Yanyin Yang, Senior Scientist II (