The US Food and Drug Administration (FDA) has granted final approval to Zydus Lifesciences for Cevimeline Hydrochloride Capsules 30 mg, the generic version of 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.

The capsules had annual sales of USD 26.9 million.

The group now has 436 approvals and has so far filed 505 ANDAs since the commencement of the filing process in FY 2003-04.