16th Oct 2015 06:09
LONDON (Alliance News) - AstraZeneca PLC on Friday said the US Food and Drug Adminstration has published a Complete Response Letter on the New Drug Application made for the fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adult patients with type 2 diabetes.
The letter said more clinical data will be required to support the application for the drug, and AstraZeneca said it will work with the US regulator to take the appropriate next steps on the application.
The conclusions made by the FDA are not expected to affect the individual approvals for saxagliptin and dapagliflozin in treating type 2 diabetes.
By Sam Unsted; [email protected]; @SamUAtAlliance
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