Onglyza has been submitted for regulatory review in more than 50 countries and is approved in 38 countries, including the US and member states of the EU. Onglyza was approved by the FDA in July 2009 and is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus.
Reportedly, Bristol-Myers Squibb and AstraZeneca have submitted the NDA with the FDA for saxagliptin/metformin HCl extended-release tablets on December 29, 2009.
Both the parties said that Onglyza NDA is based on bioequivalence data and data from the Onglyza Phase 3 clinical trial program which included studies for the co-administration of Onglyza and immediate release metformin, as an adjunct to diet and exercise, in adult patients with type 2 diabetes inadequately controlled on metformin alone and in treatment-naive adult patients.