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# AstraZeneca Gets ‘Complete Response’ on Farxiga sNDA
- URL: https://www.fdaweb.com/astrazeneca-gets-complete-response-on-farxiga-snda/
- Published: 2019-07-15T12:00:00.000Z
- Updated: 2026-09-15T01:37:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144529

FDA has issued AstraZeneca a complete response letter on a supplemental NDA for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycemic control in adult patients with Type-1 diabetes, when insulin alone does not provide adequate control. The drug was recently approved in Europe and Japan for the same indication. Farxiga, a once-daily selective inhibitor of SGLT2, is currently indicated as both monotherapy and as part of combination therapy to improve glycemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with Type 2 diabetes. AstraZeneca says it will work closely with FDA to discuss its next steps.