The pharmaceutical company announced that its subsidiary, Zydus Worldwide DMCC secured a tentative approval from the US-based drug regulatory body, United States Food and Drug Administration (USFDA) to market Selexipag tablets.
Selexipag is used in adults to treat pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalization for PAH. Selexipag is a prostacyclin receptor agonist. The drug will be manufactured at group's formulation facility at SEZ (Special Economic Zones), Ahmedabad, the company said.
As per IQVIA MAT March 2022 data, the tablets had annual sales of $551 million in the United States. Currently, the group has 331 approvals and has so far filed over 400 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04, the company stated.
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. On a consolidated basis, the company's net profit fell 5.08% to Rs 500.40 crore on 0.61% increase in revenue from operations to Rs 3,655 crore in Q3 FY22 over Q3 FY21.
Shares of Zydus Lifesciences were trading 0.47% lower at Rs 338.80 on BSE.
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