The regulatory decision represents the first new drug application (NDA) approval secured by the speciality pharmaceutical manufacturer.
Cosette expects the therapy to be commercially accessible in the US by late 2026, with further distribution details scheduled for release nearer to the commercial launch.
It conceived and formulated the therapy internally to provide an option for adult Sjögren’s disease patients who face difficulties when swallowing traditional solid capsules.
The chronic autoimmune condition damages the body’s moisture-producing glands, primarily causing dry mouth and eyes, which can impede a patient’s capacity to ingest capsule-based treatments.
The active ingredient in the newly approved formulation is cevimeline hydrochloride, identical to the compound used in existing Evoxac capsules authorised for adult dry mouth in Sjögren’s disease.
Cosette utilised a streamlined regulatory pathway that allowed it to reference historical safety and efficacy findings from Evoxac capsules, avoiding a full-scale clinical development programme.
Cosette Pharmaceuticals president and CEO Apurva Saraf said: “Evoxac oral solution marks an important milestone for Cosette—our first NDA approval, achieved through the dedication and ingenuity of our own teams.
“Today, we are demonstrating that we can also create value through our own product development capabilities. I am incredibly proud of our teams and excited about what this achievement makes possible for the patients and our future.”
Evoxac is a prescription medicine whose paediatric safety and effectiveness remain unconfirmed.
The therapy is associated with potential adverse effects, including heart rhythm and heart rate issues, lung complications such as restricted airflow and increased mucus, vision alterations particularly in darkness, and nervous system disorders linked to cholinergic reactions.