Drug and Device Update

FDA approves Xigduo XR

The combination of dapagliflozin (Farxiga) and metformin hydrochloride extended release (Xigduo XR) is designed for use with diet and exercise to improve glycemic control. The drug was approved with multiple dosage strengths of dapagliflozin and metformin hydrochloride extended release, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg and 10 mg/1,000 mg, respectively, according to the release. The starting dose would be individualized based on a patient’s current treatment regimen.

The FDA approved the treatment after four phase 3 clinical trials in adults with type 2 diabetes offered evidence for the efficacy and safety in patients receiving no treatment and in those inadequately controlled on metformin immediate and extended release. The immediate-release formula is already approved in the European Union and the extended release in Australia. The most common adverse reactions have included female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea and headache, according to the statement.

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