Zydus Lifesciences Gains USFDA Approval for Cevimeline Capsules
Filing Summary
Zydus Lifesciences Ltd has received final approval from the USFDA for its Cevimeline Hydrochloride Capsules 30mg. This approval is for the treatment of dry mouth associated with Sjögren’s syndrome. The capsules will be manufactured at Zydus’s facility in Ahmedabad. The product had annual sales of USD 27 million as per IQVIA MAT Jan-26. Zydus has now secured 436 approvals and filed 505 ANDAs since FY 2003-04.
Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) for its Cevimeline Hydrochloride Capsules 30mg. The approval is for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren’s syndrome. Cevimeline is a muscarinic receptor agonist that stimulates salivary secretion.
The capsules will be produced at Zydus’s manufacturing facility located at SEZ-II, Ahmedabad. According to IQVIA MAT Jan-26, Cevimeline Hydrochloride Capsules 30mg had annual sales of approximately USD 27 million.
Zydus has now achieved a total of 436 approvals and has filed 505 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences Ltd focuses on the development and manufacturing of pharmaceutical products. The company prioritizes expanding its portfolio of approved drugs and enhancing its manufacturing capabilities to meet global healthcare needs.