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Fosamprenavir Calcium

Type of Posting: Notice of Intent to Revise
Posting Date: 25-Nov-2022
Targeted Official Date: TBD
Expert Committee: Small Molecules 1

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 1 Expert Committee intends to revise the Fosamprenavir Calcium monograph, which was posted on June 1, 2022 and scheduled to become official on December 1, 2022.

Comments were received indicating that the acceptance criteria for water determination test should be revised to accommodate other approved products using a different form of fosamprenavir calcium. Based on the review of supporting data, it was found that Fosamprenavir Calcium may also be present in amorphous form, which may not be able to meet the “NLT 11.5%” acceptance criteria in the water determination test. The Expert Committee intends to revise the Fosamprenavir Calcium monograph to delete the lower limit and widen the acceptance criteria from “11.5%-14.5%” to “NMT 14.5%” in the water determination test.

It is anticipated that this revision will be implemented using a suitable accelerated revision process and may become official later than December 01, 2022.

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