The FDA declined to approve sotagliflozin for type 1 diabetes in a complete response letter issued in March 2024.
Campbell P. FDA approves Sotagliflozin for treatment of heart failure. HCP Live. Accessed J.
approval of sotagliflozin. For an approval decision, FDA must evaluate each drug based on its specific benefits and risks. As discussed above, the evidence
FDA Approves Sotagliflozin for Treatment of Heart Failure. Results from 2 studies led to the US approval of sotagliflozin.2,3 The phase
Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, gains FDA approval for heart failure and diabetes patients with cardiovascular risks.
Lexicon announces FDA approval of Inpefa (sotagliflozin) for treatment of heart failure. News release. Lexicon. Accessed .
The FDA has approved Lexicon Pharmaceuticals 39; Inpefa (sotagliflozin) to cut the risk of cardiovascular death and hospitalization for
Inpefa (sotagliflozin) – New drug approval. On, Lexicon Pharmaceuticals announced the FDA approval of Inpefa (sotagliflozin), to.
FDA Approves Sotagliflozin For Heart Failure Across Full Range of LVEF The medication is broadly approved for heart failure with preserved or
Comments
What the hell would the FDA have to do with it? This is a piece of machinery. They would have NO say about it whatsoever.
Good story - would like to see more!
Do you realize the world doesn't end at USA borders?