FDA approves new Evoxac capsule formulation for Cosette Pharmaceuticals

The FDA approved a new drug application for Evoxac, submitted by Cosette Pharmaceuticals NC, under a Type 3 new dosage form submission classification. The application covers an oral capsule formulation containing cevimeline hydrochloride at a 30 milligram strength, listed under application number NDA221183.¹

The submission was reviewed under standard priority status rather than priority review. FDA records list the submission status as approved (AP), with a submission status date of October 15, 2026.¹ The agency's approval letter itself is dated October 19, 2026, as reflected in the application documentation on file.

This marks the first original submission for this particular application number, designated as submission number 1 in FDA's Drugs@FDA database. No additional details on indication, dosing regimen, or clinical data supporting the new dosage form were included in the available regulatory record.