STEGLATRO

批准信原文要点

This Prior Approval sNDA was submitted in response to our October 24, 2025, Supplement Request letter and provides for: updates to Section 5 regarding the risk of Fournier’s gangrene in patients without diabetes mellitus; combining three related genitourinary infections Warnings and Precautions into a single subsection; and updates to Section 5.2 Lower Limb Amputation to improve clarity and align with current labeling for other SGLT2 products.

批准信原文要点

This corrected action letter incorporates the correction of the error. The effective action date will remain December 20, 2024, the date of the original letter. These “Changes Being Effected” sNDAs provide for the addition of “rash” to subsection 6.2 Postmarketing Experience, of section 6 Adverse Reactions of the Prescribing Information for Steglatro, Steglujan, and Segluromet.

批准信原文要点

These Prior Approval sNDAs provide for the following updates to the Steglatro, Steglujan, and Segluromet Prescribing Information: • Revisions to the Limitations of Use statement in section 1 Indications and Usage. • Removed the contraindication in patients on dialysis in Steglatro in section 2.2 Recommended Dosage, section 4 Contraindications, and section 8.6 Renal Impairment. • Added a Temporary Interruption for Surgery section under section 2 Dosage and Administration • Revisions to the Warnings and Precautions Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis section of section 5 Warnings and Precautions to reorganize and streamline the risk and mitigation clearly and succinctly and also include new information pertaining to prolonged diabetic ketoacidosis and glucosuria.

批准信原文要点

These sNDAs provide for revisions to the labeling for Steglatro, Steglujan and Segluromet, consistent with our July 1, 2022, letter and the comments sent to you in our August 31, 2022, September 21, 2022, and September 26, 2022, correspondences.

批准信原文要点

These Prior Approval sNDAs provide for updates to the prescribing information (PI) for each product based on the results of study MK-8835-004/B1521021, entitled “Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes following Treatment with Ertugliflozin (MK-8835/PF- 04971729) in Subjects with Type 2 Diabetes Mellitus and Established Vascular Disease, the VERTIS CV Study.” Updates were also made to the medication guide (MG) for each product to align with the PI.

批准信原文要点

These sNDAs provide for revisions to the labeling for Steglatro, Steglujan, and Segluromet, consistent with our October 21, 2019, letter and the comments sent to you in our December 19, 2019, correspondence.

批准信原文要点

This supplemental new drug application provides for revisions to the labeling for Steglatro consistent with our August 29, 2018, Safety Labeling Change Notification letter, and the comments sent to you in our October 5, 16, 17, and 18, 2018, correspondence.