Zydus receives final approval from USFDA for Cevimeline Hydrochloride Capsules 30mg
The group now has 436 approvals and has so far filed 505 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences 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).