Zydus receives final US FDA nod for Valsartan Tablets
Valsartan tablets had annual sales of $149.5 mn in the United States (IQVIA MAT May 2024)
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Valsartan Tablets USP, 40 mg, 80 mg, 160 mg and 320 mg (USRLD: Diovan tablets).
Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and paediatric patients one year of age and older. It is also used in adults to treat heart failure (a condition in which the heart is unable to pump enough blood to the rest of the body) and to improve survival after a heart attack.
The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ – II, India. Valsartan tablets had annual sales of $ 149.5 mn in the United States (IQVIA MAT May 2024). The group now has 400 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04. (*as of 31st March 2024)
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