logo
  

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Royal Caribbean Group's ultra-luxury brand Silversea Cruises is set to launch the world's first hybrid-powered cruise ship in the summer of 2023. This will also be the first ship with large-scale fuel cell technology to enable emission-free port operations. The fuel cells will provide 100% of power while at port. Affco USA is recalling around 24,461 pounds of frozen raw lamb shoulder products that were not presented for import re-inspection into the U.S., the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS announced. The recall involves the frozen raw lamb shoulder items that were imported on July 12, 2021. American Express Company (AXP) reported an increase in profit for the third quarter that also topped Wall Street estimates. Consolidated total revenues net of interest expense rose 25 percent year-on-year, primarily reflecting growth in Card Member spending, as well as a rise in the average discount...
Follow RTT