Advertisement

FDA Tentatively Approves Generic Farxiga

Text Size:
FDA Tentatively Approves Generic Farxiga

The U.S. Food and Drug Administration (FDA) has tentatively approved a marketing application from pharmaceutical manufacturer Sandoz for a generic version of the oral type 2 diabetes medication Farxiga (generic name dapagliflozin). Tentative approval means that the application met approval criteria but patent issues need to be resolved before full approval is granted.

Farxiga is a member of a class of drugs known as SGLT2 inhibitors. SGLT2, or sodium-glucose cotransporter-2, is a protein that helps the kidneys reabsorb glucose from filtered blood. SGLT2 inhibitors prevent the body from reabsorbing this glucose, allowing it to instead be passed out in the urine.

Advertisement

To get cutting-edge diabetes news, strategies for blood glucose management, nutrition tips, healthy recipes, and more delivered straight to your inbox, sign up for our free newsletter!

The FDA earlier this month declined Farxiga for use as a treatment in type 1 diabetes. The medicine was granted approval as an adjunct treatment for certain adults with type 1 diabetes by the European Commission earlier this year.

Want to learn more about SGLT2 inhbitors? Read “Diabetes Medicine: SGLT2 Inhbitors.”

Diane Fennell

Diane Fennell

Senior Digital Editor for DiabetesSelfManagement.com, Fennell has 16 years’ experience specializing in diabetes and related health conditions. Based in New York City, she has a degree from Columbia University.

Get Diabetes-Friendly Recipes In Your Inbox

Sign up for Free

Stay Up To Date On News & Advice For Diabetes

Sign up for Free

Get On Track With Daily Lifestyle Tips

Sign up for Free

Save Your Favorites

Save This Article