Zydus receives tentative approval from USFDA for Azilsartan Medoxomil Tablets, 40 mg and 80 mg

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") has received tentative approval from the United States Food and Drug Administration (USFDA) to market Azilsartan Medoxomil Tablets, 40 mg and 80 mg (USRLD: Edarbi® tablets).

Azilsartan is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Azilsartan medoxomil tablets may be used either alone or in combination with other antihypertensive agents. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India.

Azilsartan Medoxomil Tablets had annual sales of USD 89 mn in the United States (IQVIA MAT March 24).

The group now has 398 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)

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 1137.20 as compared to the previous close of Rs. 1094.65. The total number of shares traded during the day was 196069 in over 5778 trades.

The stock hit an intraday high of Rs. 1144.00 and intraday low of 1093.20. The net turnover during the day was Rs. 219177576.00.

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 USFDA TentativeApproval ANDA AzilsartanMedoxomilTablets