Xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: • in patients insufficiently controlled on their maximally tolerated dose of metformin alone • in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products • in patients already being treated with the combination of dapagliflozin and metformin as separate tablets. For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
METFORMIN HYDROCHLORIDE — GLENMARK PHARMS LTD, approved 2019-11-25 (ANDA212969).
58,064 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.