Cosette Pharma Wins FDA Approval for EVOXAC Oral Solution

Cosette Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for EVOXAC (cevimeline hydrochloride) oral solution to treat symptoms of dry mouth in adults with Sjögren’s disease. The approval marks the company’s first New Drug Application (NDA) approval and introduces a new formulation designed to help patients who may have difficulty swallowing capsules.

Announced on October 20, 2026, the approval is an important milestone for Cosette as it expands its product development capabilities. The company developed the oral solution through its internal teams, from the initial concept to regulatory approval.

Sjögren’s disease is a chronic autoimmune condition that affects the glands responsible for producing moisture in the body. It commonly causes dry eyes and dry mouth, although it can also affect other parts of the body and lead to symptoms such as fatigue and joint pain. For some patients, severe dryness can make swallowing medicines in capsule form difficult.

EVOXAC oral solution contains cevimeline hydrochloride, the same active ingredient found in the already approved EVOXAC capsules. The medicine helps increase saliva production, providing relief from dry mouth symptoms associated with Sjögren’s disease.

The new formulation offers an alternative for adults who need treatment but find capsules difficult to swallow. By developing the medicine in liquid form, Cosette aims to address a practical challenge faced by some patients while using an established active ingredient.

To secure approval, Cosette relied partly on existing safety and effectiveness data for the approved EVOXAC capsules through an established FDA regulatory pathway. This approach allowed the company to support approval of the new formulation without conducting a full-scale clinical development programme.

According to Cosette, developing the oral solution required extensive work on formulation and the scientific evidence needed for regulatory review. Teams across research and development, regulatory affairs, quality and manufacturing contributed to the project.

Apurva Saraf, president and chief executive officer of Cosette Pharmaceuticals, said the approval demonstrates the company’s ability to develop new formulations of established medicines and respond to patient needs through its own research and development capabilities.

The company expects EVOXAC oral solution to become commercially available in the United States by the end of 2026. Further details about its availability will be shared closer to launch.

The approval also highlights the role of formulation development in pharmaceutical innovation. While developing entirely new medicines remains important, creating alternative forms of existing treatments can help address practical barriers to treatment and improve the experience of patients living with chronic conditions.

For Cosette, the FDA decision represents a step beyond its established branded medicines business and demonstrates its ability to develop products internally. The company plans to continue building its capabilities in product development while focusing on treatments that address unmet patient needs.