BRIEF—US FDA gives tentative approval for sitagliptin generic

India’s Zydus Cadila has received the tentative approval from the US Food and drug administration for sitagliptin tablets USP, 25mg, 50mg and 100mg.

The drug is a generic version of Merck & Co’s Januvia/Janumet (sitagliptin), which generated second quarter 2018 sales of $1.54 billion, up 2%

It will be manufactured at the Zydus group’s formulations manufacturing facility at SEZ, Ahmedabad.

Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in patients with type 2 diabetes. Sitagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amounts of certain natural substances that lower blood sugar when it is high.