Cosette Pharmaceuticals Announces FDA Approval of EVOXAC® (cevimeline HCl) Oral Solution, Marking Cosette’s First New Drug Application (NDA) Approval
Key Highlights
- ➤FDA approves Cosette’s EVOXAC oral solution for Sjögren’s-related dry mouth
- ➤EVOXAC approval marks Cosette’s first New Drug Application approval
- ➤U.S. commercial availability expected by end of 2026
- ➤Cosette used existing capsule safety and efficacy data under streamlined FDA process
Expert Statements
Apurva Saraf, President and Chief Executive Officer of Cosette Pharmaceuticals
“EVOXAC(®) oral solution marks an important milestone for Cosette—our first NDA approval, achieved through the dedication and ingenuity of our own teams”
Apurva Saraf, President and Chief Executive Officer of Cosette Pharmaceuticals
“It brings to life what we mean by Innovating Every Day: looking at established medicines in new ways to address real patient needs.”
Apurva Saraf, President and Chief Executive Officer of Cosette Pharmaceuticals
“We have built Cosette by acquiring and strengthening trusted brands. Today, we are demonstrating that we can also create value through our own product development capabilities.”
Apurva Saraf, President and Chief Executive Officer of Cosette Pharmaceuticals
“I am incredibly proud of our teams and excited about what this achievement makes possible for the patients’ and our future.”
Ravi Patel, Vice President, Scientific Affairs at Cosette Pharmaceuticals
“Developing EVOXAC(®) oral solution required us to solve a complex formulation challenge and generate the scientific evidence needed to support regulatory review.”
Ravi Patel, Vice President, Scientific Affairs at Cosette Pharmaceuticals
“By leveraging an established regulatory pathway and the existing body of evidence for cevimeline, our teams were able to take a focused approach to development.”
Ravi Patel, Vice President, Scientific Affairs at Cosette Pharmaceuticals
“This achievement reflects years of scientific work and collaboration across R&D, Regulatory, Quality, Manufacturing and other functions, and I'm incredibly proud of everyone who contributed.”
Cosette Pharmaceuticals Announces FDA Approval of EVOXAC(®) (cevimeline HCl) Oral Solution, Marking Cosette’s First New Drug Application (NDA) Approval
– – New Oral Solution Formulation Developed for Patients Living with Sjögren’s Disease demonstrates Cosette's expanding capabilities in product development and innovation – –
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