Zydus Lifesciences Receives USFDA Approval for Cevimeline 30 mg Capsules

Zydus Lifesciences has received final approval from the US Food and Drug Administration for Cevimeline Hydrochloride Capsules 30 mg, a generic version of Evoxac used to treat dry mouth associated with Sjögren's syndrome. The capsules will be manufactured at Zydus's facility in Ahmedabad. The product had annual US sales of $26.9 million as of January 2026. This approval adds to Zydus's portfolio of 436 USFDA approvals and 505 ANDA filings since 2003-04.