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FDA Accepts Teva, MedinCell NDA For Schizophrenia Treatment

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), and MedinCell (MEDCL) Tuesday said that the New Drug Application for TV-46000/mdc-IRM for the treatment of schizophrenia has been accepted by the U.S. Food and Drug Administration.

FDA accepted the NDA based on the phase 3 data from two pivotal studies. These studies evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia.

"The advancements made in managing mental health conditions over the past decade have been shaped by offering patients new treatment options. Now, we are taking the same approach with long-acting treatments, using advanced science to improve disease outcomes for those living with schizophrenia," said Dr. Hafrun Fridriksdottir, Executive Vice President, Global R&D, at Teva. "We're pleased to share news of this progress as we move one step closer to potentially bringing a new treatment option to patients in need."

Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts. Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.

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