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.

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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.

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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.

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