Lupin got tentative approval for metformin ER tablets by USFDA

USFDA has given tentative approval to lupin for its AB rated generic equivalent of Andrx Labs LLC’s Fortamet 500mg and 1000 mg tablets, FORTAMET(R). Fortamet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.


As per Lupin's view, they are the first to file ANDA with paragraph IV certification, they will get the 180 days exclusivity on this product.  

New diabetes combo approved by USFDA

USFDA has approved combination dosage form for type 2 diabetes treatment in adults. This product is in the form of tablet dosage from and contains metformin in extended release form and saxagliptin. Brand name of this combo is Kombiglyze XR.
This combination is made up of combination of two pharma major companies also ie AstraZeneca and Bristol Myers Squibb.