Tag: Regulatory

In late 2024, the FDA's advisory committee delivered an 11-3 vote against approving sotagliflozin (brand name Zynquista) for type 1 diabetes patients with chronic kidney disease. This decision marked the second major setback for the drug in this indication, as the FDA rejected sotagliflozin once again over persistent and unmitigated concerns about a heightened risk of diabetic ketoacidosis (DKA).

The United States Prescribing Information (USPI) serves a similar function to the EU's Summary of Product Characteristics (SmPC), providing vital drug information for healthcare professionals. While both documents detail a drug's approved usage, safety, and effectiveness, significant differences in format, content, and regulatory oversight mean they are not identical. This article clarifies what is the US equivalent of SmPC and explores the distinctions that affect prescribers and manufacturers alike.