Zydus Lifesciences wins USFDA okay for hypertension drug Valsartan

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-07-23 09:12 GMT | Update On 2024-07-23 09:12 GMT

Ahmedabad: Zydus Lifesciences Limited 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 USD 149.5 mn in the United States (IQVIA MAT May 2024).

Medical Dialogues team had earlier reported that the Company had received final approval from the USFDA to market Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (USRLD: Entresto tablets).

Sacubitril and Valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalization.

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.

Read also: USFDA nod to Zydus Lifesciences chronic heart failure drug

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Zydus has been actively discovering and developing New Chemical Entities (NCEs) novel biologicals, several biosimilars and vaccines as a part of its innovation pipeline. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Zydus Lifesciences wins USFDA okay for hypertension drug Valsartan

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