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Metformin/saxagliptin combination approved for type 2 diabetes
Once-daily metformin extended-release plus dipeptidyl peptidase-4 tablet. Th e combination therapy (Kombiglyze XR; Bistol-Myers Squibb, AstraZeneca) was approved for patients with type 2 diabetes and is indicated in conjunction with diet and exercise for adults with type 2 diabetes.
FDA approval was based on two phase 3 trials and bioequivalence studies that demonstrated the safety and effi cacy of metformin and saxaglipin (Onglyza; Bristol- Myers Squibb, AstraZeneca) as separate tablets. Used together, the drug resulted in signifi cant reductions in HbA1c level, fasting plasma glucose and postprandial glucose, according to the companies.
Th e tablet should be administered once daily with the evening meal and should be titrated to reduce metforminassociated gastrointestinal adverse events. Th e maximum daily recommended dose is 5 mg saxaglipin and 2,000 mg metformin ER. Th e drug has not been studied in combination with insulin and should not be used in patients who have type 1 diabetes or diabetic ketoacidosis.
Dexamethasone sodium phosphate injection recalled
American Regent and the FDA have notifi ed health care professionals of a nationwide, voluntary recall of specifi c lots of dexamethasone sodium phosphate injection that was initiated in late December. Some vials may contain particulates or have the potential to form particulates before their respective expiration dates, the FDA said.
Th e recall aff ects the USP 4 mg/mL, 30 mg/mL multiple dose vial. Th e recalled lots include: #8811 with expiration date of December 2010; #9093 with expiration date of February 2011; #9195 with expiration date of March 2011; #9296...