Zydus Lifesciences announced that it has received tentative approval from United States Food and Drug Administration (USFDA) to market Bosentan and Canagliflozin tablets.
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 tablet is a reference listed drug of Tracleer tablets for oral suspension. According IQVIA MAT December 2022, Bosentan tablet had annual sales of $16 million.
Canagliflozin tablet is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The drug will be manufactured at the group's formulation manufacturing facility at Moraiya.
Canagliflozin tablet is a reference listed drug of Invokana tablets. According IQVIA MAT December 2022, Canagliflozin tablet had annual sales of $660 million.
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.
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
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