Endocrinology's Top FDA Approvals in 2021

Endocrinology's Top 5 FDA Approvals in 2021

1. FreeStyle Libre 2 App Receives Clearance from US FDA for Diabetes Management
   Abbott announced the FDA's clearance of their FreeStyle Libre 2 iOS app, which the company suggests is the only sensor-based glucose monitoring app that allows users to check their glucose with a compatible iPhone every minute with optional real-time glucose alarms, in a release on August 2.
   
2. FDA Approves SKYTROFA, First Once-Weekly Treatment for Growth Hormone Deficiency in Children
   With approval awarded to Ascendis Pharma on August 25, lonapegsomatropin-tcgd (SKYTROFA) becomes the first once-weekly injection approved by the FDA to deliver somatropin by sustained release over a 1-week period.
   
3. FDA Approves Dapagliflozin for Treatment of Chronic Kidney Disease
   With approval in late April, dapagliflozin becomes the first SGLT2 inhibitor to receive approval for treatment of chronic kidney disease, heart failure, and type 2 diabetes.
   
4. FDA Approves Semglee, Its First Interchangeable Biosimilar Insulin Product
   Announced on July 28, insulin glargine-yfgn (Semglee) becomes the first interchange biosimilar insulin product to receive approval in the FDA's history and is expected to be available by the end of the year.
   
5. FDA Makes Historic First Approving NEXTSTELLIS, an Oral Contraceptive Containing E4
   The approval, which was awarded to Mayne Pharma, makes NEXTSTELLIS the first and only contraceptive pill containing E4, a natural occurring estrogen to receive approval from the FDA.