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Routine Notice Amended Final

Dapagliflozin Tablets Monograph Revision Notice

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Published June 1st, 2026
Detected March 12th, 2026
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Summary

The USP is issuing a notice of intent to revise the Dapagliflozin Tablets monograph, with a targeted official date of June 1, 2026. This revision is being made in response to comments received, aiming to incorporate feedback into the monograph.

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What changed

The United States Pharmacopeia (USP) has issued a Notice of Intent to Revise the Dapagliflozin Tablets monograph. This revision, with a targeted official date of June 1, 2026, is a response to comments received by the Small Molecules 3 Expert Committee, indicating a need for further consideration of the monograph's content. The original monograph was published on September 26, 2025, and was scheduled to become official on April 1, 2026.

This notice is primarily informational for drug manufacturers and pharmaceutical companies involved with Dapagliflozin. While no immediate compliance actions are required, stakeholders should be aware of the upcoming revision and its potential impact on product standards. The USP intends to incorporate relevant comments into the monograph, and the new official date provides a clear timeline for these changes.

Source document (simplified)

Dapagliflozin Tablets

Type of Posting: Notice of Intent to Revise
Posting Date: 11-Feb-2026; updated 26-Feb-2026
Targeted Official Date: 01-Jun-2026; Revision Bulletin
Expert Committee: Small Molecules Therapeutic Area 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 Dapagliflozin Tablets monograph. This monograph was published on September 26, 2025, and was scheduled to become official on April 1, 2026.

Comments with supporting data were received indicating that additional consideration of content of this monograph is needed. USP intends to revise this monograph to incorporate the comments, as appropriate. The new anticipated official date is June 1, 2026.

Should you have any questions, please contact Ren-Hwa Yeh, Senior Manager (rhy@usp.org).

This Notice was updated on February 26, 2026 to provide a new anticipated official date and revision vehicle.

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Source

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USP Compendial Notices uspnf.com/notices/new
Drug Safety
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Classification

Agency
Various
Published
June 1st, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Geographic scope
National (US)

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Drug Manufacturing Regulatory Standards

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