Zydus receives tentative approval from the USFDA for Bosentan Tablets for Oral Suspension

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 Bosentan Tablets for Oral Suspension, 32 mg (USRLD: Tracleer® Tablets for Oral Suspension).

Bosentan Tablet for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) in pediatric patients aged 3 years and older with idiopathic or congenial PAH to improve pulmonary vascular resistance (PVR). The drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad.

Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022).

The group now has 341 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 469.20 as compared to the previous close of Rs. 472.85. The total number of shares traded during the day was 60713 in over 1159 trades.

The stock hit an intraday high of Rs. 474.70 and intraday low of 466.20. The net turnover during the day was Rs. 28416784.00.

(*as of 31st December 2022)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 USFDA TentativeApproval BosentanTablets OralSuspension