Zydus Lifesciences 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, via an exchnage filing.
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 th commencement of the filing process in FY 2003-04.
(To receive our E-paper on WhatsApp daily, please click here. To receive it on Telegram, please click here. We permit sharing of the paper's PDF on WhatsApp and other social media platforms.)