Ahmedabad: Zydus Lifesciences Limited., (“Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Cevimeline Hydrochloride Capsules 30 mg, (USRLD: Evoxac® Capsules, 30 mg).
Cevimeline Hydrochloride Capsules 30mg are indicated for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren’s syndrome. Cevimeline is a muscarinic receptor agonist that stimulates salivary secretion. Cevimeline hydrochloride 30 mg capsules will be produced at the Group’s manufacturing facility at SEZ-II, Ahmedabad.
Cevimeline Hydrochloride Capsules 30mg had annual sales of USD 26.9 mn. (IQVIA MAT Jan-26).
The group now has 436 approvals and has so far filed 505* ANDAs since the commencement of the filing process in FY 2003-04.
