Zydus Gets USFDA Approval for Generic Evoxac (Cevimeline) Capsules
New Delhi: Zydus Lifesciences Limited has received final approval from the U.S. Food and Drug Administration (USFDA) for Cevimeline Hydrochloride Capsules 30 mg, the generic version of Evoxac Capsules 30 mg.
Cevimeline Hydrochloride Capsules 30 mg are indicated for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren’s syndrome. The drug acts as a muscarinic receptor agonist that stimulates salivary secretion. According to the company, the capsules will be manufactured at the group’s SEZ-II manufacturing facility in Ahmedabad.
As per market data, Cevimeline Hydrochloride Capsules 30 mg recorded annual sales of approximately USD 26.9 million in the United States as of January 2026, based on IQVIA MAT data.
With this approval, the company’s cumulative approvals from the USFDA have reached 436. Zydus Lifesciences has also filed a total of 505 Abbreviated New Drug Applications (ANDAs) since it began the filing process in FY 2003–04.
The company informed stock exchanges that a press release dated March 13, 2026 titled “Zydus receives final approval from USFDA for Cevimeline Hydrochloride Capsules 30mg” has been issued to provide detailed information to investors and stakeholders.
