Zydus Cadila gets tentative FDA approval for generic Janumet XR

3/14/2019
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.
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