FDA Approves Zituvimet

Tue Nov 07 10:49:30 CST 2023

November 06, 2023, Ahmedabad, India -- Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Zituvimet (Sitagliptin and Metformin hydrochloride) tablets, 50 mg/500 mg and 50 mg/1000 mg.

Zituvimet contains active ingredients sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The approval of Zituvimet is based on research, development, regulatory, and manufacturing work performed by Zydus teams. Zituvimet has undergone quality testing for Nitrosamines and potential genotoxic impurities as per current USFDA standards. Zituvimet is compliant with current USFDA standards of Nitrosamines in Sitagliptin containing products.

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“The Zituvimet approval further builds on our previous approval of Zituvio (sitagliptin) and offers an increased accessibility and affordability to healthcare systems with regard to prescription drugs for type II diabetes. The Zituvimet approval provides an affordable treatment option for healthcare systems to reduce the rate of growth in drug spending and improves the financial sustainability of the healthcare programs,” said Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited.

According to IQVIA™ (MAT Aug-2023), U.S. market for DPP-IV inhibitors and their combinations is US$ 10 bn.

About Zydus

The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 25000 people worldwide and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through pathbreaking discoveries. For more details visit

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Zituvimet is a fixed dose combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

Zituvimet is not recommended in patients with type 1 diabetes mellitus.

Zituvimet has not been studied in patients with a history of pancreatitis.

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The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin and 500 mg metformin HCl twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin. (2.1)

The starting dose in patients already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken. For patients taking metformin HCl 850 mg twice daily, the recommended starting dose of Zituvimet is 50 mg sitagliptin and 1,000 mg metformin HCl twice daily. (2.1). Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m2.


The FAI climbed 5.9 percent year-on-year in the first 11 months of 2018, quickening from the 5.7-percent growth in Jan-Oct, the National Bureau of Statistics (NBS) said Friday in an online statement.

The key indicator of investment, dubbed a major growth driver, hit the bottom in August and has since started to rebound steadily.

In the face of emerging economic challenges home and abroad, China has stepped up efforts to stabilize investment, in particular rolling out measures to motivate private investors and channel funds into infrastructure.

Friday's data showed private investment, accounting for more than 60 percent of the total FAI, expanded by a brisk 8.7 percent.

NBS spokesperson Mao Shengyong said funds into weak economic links registered rapid increases as investment in environmental protection and agriculture jumped 42 percent and 12.5 percent respectively, much faster than the average.

In breakdown, investment in high-tech and equipment manufacturing remained vigorous with 16.1-percent and 11.6-percent increases respectively in the first 11 months. Infrastructure investment gained 3.7 percent, staying flat. Investment in property development rose 9.7 percent, also unchanged.