Zydus Lifesciences Gets USFDA Nod For Cevimeline Hydrochloride Capsules 30mg

Regulatory Approval
The approval allows Zydus to expand its product portfolio in the US generics market. Cevimeline Hydrochloride Capsules are classified as AB-rated, meaning they are therapeutically equivalent to the reference listed drug Evoxac, manufactured by Cosette Pharmaceuticals.

Therapeutic Use
Cevimeline is prescribed to stimulate saliva production in patients suffering from Sjögren’s syndrome, a condition that causes severe dryness in the mouth and eyes due to reduced glandular function. The drug’s approval strengthens Zydus’s presence in the niche therapeutic segment of autoimmune disorders.

Market Impact
With this approval, Zydus Lifesciences is expected to enhance its US generics footprint, tapping into a market where demand for affordable treatments for chronic conditions remains strong. The launch is anticipated to contribute positively to the company’s revenue growth in FY2026.

Key Highlights

• Zydus Lifesciences receives USFDA approval for Cevimeline Hydrochloride Capsules 30mg
• Generic equivalent of Evoxac, used for Sjögren’s syndrome treatment
• AB-rated, ensuring therapeutic equivalence with the reference drug
• Strengthens Zydus’s US generics portfolio in autoimmune therapy segment
• Expected to boost revenue growth in FY2026

Sources: MoneyControl, DailyMed, Aurobindo Pharma USA