Zydus Cadila gets tentative FDA approval for generic Janumet XR
Zydus Cadila has received tentative approval from the Food and Drug Administration for its generic Janumet XR (sitagliptin and metformin hydrochloride extended-release tablets).
The product is used in the management of Type 2 diabetes.
The product is the generic of Merck’s Janumet XR, 50 mg/500 mg, 50 mg/1,000 mg and 100 mg/1,000 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.