Drug firm Zydus Cadila on Monday said it has received approval from the US health regulator to market Sitagliptin, a medicine indicated to treat diabetes. The company said its subsidiary has received tentative approval from the United States Food and Drug Administration (FDA) for its new drug application for Sitagliptin base 25, 50 and 100 mg tablets.
On October 31, 2020, Zydus had filed a new drug application (NDA) with the USFDA seeking approval to market Sitagliptin base 25, 50 and 100 mg tablets.
The NDA received tentative approval upon completion of the first review cycle on September 2, 2021, Zydus Cadila stated.
Zydus Cadila discovers, develops, manufactures, and markets a broad range of healthcare therapies including small molecule drugs, biologic therapeutics, and vaccines.
The group employs around 23,000 people worldwide.