The US health authorities approved Sitagliptin for marketing, which was recommended to treat diabetes, on Monday, Drug company Zydus Cadila said. The business said its affiliate obtained preliminary clearance for its new Sitagliptin Base 25, 50 and 100 mg tablets from the US Food and Drug Administration (FDA).
In an application for authorisation to commercialise Sitagliptin bases 25, 50 and 100mg tablets, Zydus submitted their new medication application to the USFDA on 31 October 2020. Once the first review cycle was completed on 2 September 2021, Zydus Cadila indicated that the NDA got preliminary clearance.
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. The group employs around 23,000 people worldwide.
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