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(13 Mar 2026, 10:06)

Zydus receives USFDA approval for Cevimeline Hydrochloride Capsules 30mg


Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Cevimeline Hydrochloride Capsules 30 mg, (USRLD: Evoxac® Capsules, 30 mg).

Cevimeline Hydrochloride Capsules 30mg are indicated for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren's syndrome. Cevimeline is a muscarinic receptor agonist that stimulates salivary secretion.

Cevimeline hydrochloride 30 mg capsules will be produced at the Group's manufacturing facility at SEZ-II, Ahmedabad.

Cevimeline Hydrochloride Capsules 30mg had annual sales of USD 26.9 mn. (IQVIA MAT Jan-26).

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