FDA News

Data suggest confirmatory trials conducted for drugs granted accelerated approval by the FDA have taken a median 3.5 years to complete since 2012.

This feature articles commemorates the 10-year anniversary of the FDA's first approval of an SGLT2 inhibitor on March 29, 2013 and provides a snapshot at the class's ascent into the treatment algorithms and guidelines for type 2 diabetes, heart failure, and chronic kidney disease.

There is a June 22 PDUFA date for obeticholic acid, which if approved would become the first FDA-approved treatment for NASH.

The approval, which is for 4 mg naloxone hydrochloride nasal spray, marks the first OTC, nonprescription approval for a naloxone nasal spray and allows the product to be sold directly to consumers in a variety of retail locations well as online.

Announced on Aug. 22, the US FDA's clearance of the Omnipod 5 AID system in type 1 diabetes for patients aged 2 years and older comes less than 7 months after receiving clearance in patients aged 6 years and older.

Announced on May 13, the approval indicates Eli Lilly and Company's novel dual GLP-1/GIP agonist, tirzepatide (Mounjaro), for use as an adjunct to diet and exercise to improve blood sugar in adult patients with type 2 diabetes.

With approval on July 9, finerenone (Kerendia) becomes the first nonsteroidal mineralocorticoid receptor antagonist to receive approval for use in adults with chronic kidney disease associated with type 2 diabetes.