Endo International's Paladin Labs On Monday Announced Health Canada's Filing Acceptance Of Cenobamate Tablets As Adjunctive Therapy For Management Of Partial-Onset Seizures In Adults With Epilepsy

Paladin Labs Inc., a subsidiary of Endo International plc (NASDAQ:ENDP), announced today that Health Canada has accepted its New Drug Submission (NDS) for cenobamate tablets as an adjunctive therapy for the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy. A decision from Health Canada as to whether cenobamate tablets can be marketed and sold in Canada under this NDS is expected mid-2023.

"This is an important step in our journey to address the unmet needs of adult patients diagnosed with partial-onset seizures," said Livio Di Francesco, Vice President and General Manager of Paladin. "Paladin Labs is committed to working collaboratively with regulatory, pricing and reimbursement authorities in order to provide cenobamate to appropriate patients as quickly as possible."