FDA Tentatively Approves Generic Farxiga

The U.S. Food and Drug Administration (FDA) has tentatively authorized a advertising utility from pharmaceutical producer Sandoz for a generic model of the oral sort 2 diabetes treatment Farxiga (generic title dapagliflozin). Tentative approval signifies that the applying met approval standards however patent points must be resolved earlier than full approval is granted.

Farxiga is a member of a category of medication referred to as SGLT2 inhibitors. SGLT2, or sodium-glucose cotransporter-2, is a protein that helps the kidneys reabsorb glucose from filtered blood. SGLT2 inhibitors forestall the physique from reabsorbing this glucose, permitting it to as a substitute be handed out within the urine.

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The FDA earlier this month declined Farxiga to be used as a remedy in sort 1 diabetes. The drugs was granted approval as an adjunct remedy for sure adults with sort 1 diabetes by the European Commission earlier this 12 months.

Want to study extra about SGLT2 inhbitors? Read “Diabetes Medicine: SGLT2 Inhbitors.”

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Diane Fennell

Senior Digital Editor for DiabetesSelfManagement.com, Fennell has 16 years’ expertise specializing in diabetes and associated well being situations. Based in New York City, she has a level from Columbia University.

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