USFDA nod to Zydus Lifesciences hypertension drug

Ahmedabad: Zydus Lifesciences Limited has announced that the company 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.

Medical Dialogues team had earlier reported that Zydus Lifesciences's subsidiary Zydus Worldwide DMCC had received final approval from the United States Food and Drug Administration (USFDA) to market Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg (USRLD: Uptravi tablets).

Read also: Zydus Lifesciences subsidiary bags USFDA nod to market pulmonary arterial hypertension drug Selexipag