USFDA nod to Zydus Diabetes drug Empagliflozin

Ahmedabad: Drugmaker, Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited), has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to market Empagliflozin Tablets USP 10 mg and 25 mg. USRLD: Jardiance.

Empagliflozin is used to lower blood sugar levels in people with type 2 diabetes. It is also used to reduce the risk of stroke, heart attack, or death in people with type 2 diabetes along with heart and blood vessel disease.

Type 2 diabetes (formerly called non-insulin-dependent, or adult-onset) results from the body's ineffective use of insulin. This type of diabetes is largely the result of excess body weight and physical inactivity. 

The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.

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Empagliflozin Tablets had annual sales of USD 9,810 million in the United States according to IQVIA data (IQVIA MAT June 2022).

The group now has 319 approvals and has so far filed over 420* ANDAs since the commencement of the filing process in FY 2003-04.

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Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs. Zydus group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.

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