Zydus Receives USFDA Approval for Cevimeline HCl Capsules 30 mg

Zydus Lifesciences has received USFDA approval for Cevimeline Hydrochloride Capsules 30 mg, allowing the company to market the generic drug in the United States.

The approval from the U.S. Food and Drug Administration (USFDA) clears the way for the company to launch the medication used to treat dry mouth associated with Sjogren’s syndrome, a chronic autoimmune disorder that affects the body’s moisture-producing glands.

The newly approved product is the generic version of Evoxac, a therapy prescribed to improve saliva production in patients experiencing xerostomia, commonly linked to Sjogren’s syndrome. Cevimeline works by stimulating muscarinic receptors, which help increase the secretion of saliva and provide relief from persistent oral dryness.

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According to the company, the drug will be manufactured at Zydus Lifesciences’ SEZ-II facility in Ahmedabad, India, a site that supports the company’s growing portfolio of regulated market products. The USFDA approval for Cevimeline Hydrochloride Capsules further strengthens Zydus’ presence in the U.S. generics market, where the therapy has an established demand.

Industry data shows that Cevimeline Hydrochloride Capsules generated annual sales of about $26.9 million in the United States, based on IQVIA MAT data for January 2026. With this approval, Zydus aims to tap into that market while expanding treatment access for patients managing symptoms of Sjogren’s syndrome.

The latest clearance also adds to the company’s regulatory track record. Zydus Lifesciences now holds 436 approvals from the USFDA and has filed 505 Abbreviated New Drug Applications (ANDAs) since the start of its U.S. generics filings in FY2003-04, reflecting its continued focus on expanding its pharmaceutical footprint in regulated markets.