Inpefa

Lowers the risk of cardiovascular death, hospitalization for heart failure, and urgent…. NDA 216203, held by Lexicon Pharms Inc. Sotagliflozin.

As of Nov 13, 2026, NDA 216203 (Inpefa), held by Lexicon Pharms Inc, was first approved by FDA on May 26, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: May 26, 2023
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 26, 2023	Original applicationNew molecular entity · Standard review	Approved	Review Label Medication Guide Letter

Products

2 strengths and forms


Inpefa200MG · tablet;oral	Sotagliflozin	RxReference drug
Inpefa400MG · tablet;oral	Sotagliflozin	RxReference drug

All 2 submissions, including labeling and manufacturing supplements


Aug 6, 2026	Supplement 3Labeling · Standard review	Approved	Label Medication Guide Letter
May 26, 2023	Original applicationNew molecular entity · Standard review	Approved	Review Label Medication Guide Letter

Identifiers

Application: NDA 216203
Drugs@FDA: Overview at FDA
Company: Lexicon Pharmaceuticals, Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters