
USFDA13 Mar 2026, 10:12 am
Zydus Lifesciences receives final USFDA approval for Cevimeline Hydrochloride Capsules 30mg
AI Summary
Zydus Lifesciences Limited has received final approval from the USFDA for Cevimeline Hydrochloride Capsules 30mg. The capsules are indicated for the symptomatic treatment of dry mouth associated with Sjogren’s syndrome. Cevimeline is a muscarinic receptor agonist that stimulates salivary secretion. The annual sales of the drug were USD 26.9 mn. Zydus now has 436 approvals and has filed 505 ANDAs since FY 2003-04. The capsules will be produced at the Group’s manufacturing facility at SEZ-1I, Ahmedabad.
Key Highlights
- Zydus receives final approval from USFDA for Cevimeline Hydrochloride Capsules 30mg
- Cevimeline Hydrochloride Capsules 30mg are indicated for the symptomatic treatment of dry mouth associated with Sjogren’s syndrome
- Cevimeline is a muscarinic receptor agonist that stimulates salivary secretion
- The annual sales of Cevimeline Hydrochloride Capsules 30mg were USD 26.9 mn
- Zydus now has 436 approvals and has filed 505 ANDAs since FY 2003-04