Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for ecopipam, with a targeted action (PDUFA) date late in the first quarter of 2027. Ecopipam is a first-in-class investigational therapy for the treatment of pediatric patients with Tourette syndrome. This milestone advances Teva’s Pivot to Growth strategy by utilizing the company’s expertise in neuroscience to support patients, particularly in areas where there is high unmet need.

Tourette syndrome is a debilitating neuro-developmental condition impacting approximately 100,000 children and adolescents nationwide.2 Only half of these patients are treated with prescription medication for this condition, and only 20-30 percent remain on therapy after one year. Despite the current treatment options available, many patients continue to experience inadequate control or treatment-limiting side effects.3 This patient experience underscores the urgent need for new prescription drug options and reinforces Teva’s commitment to expanding access to innovative neuroscience treatments for underserved patient populations.