CMG Pharmaceutical wins FDA approval for Schizophrenia treatment

CMG Pharmaceutical, a chemical drug affiliate of CHA Biotech, has received approval from the U.S. Food and Drug Administration (FDA) for its schizophrenia treatment, Mezofy, the company said Wednesday. Mezofy is an oral film-type drug based on aripiprazole, a widely used antipsychotic for treating a variety of mood and psychotic disorders. This is the fourth case of a Korean pharmaceutical company securing approval for an incrementally modified drug and the first done by changing the formulation. Patients with schizophrenia and other mental health conditions often stop taking their medication voluntarily, making consistent treatment a challenge. To address this, CMG Pharmaceutical formulated Mezofy into an oral film, enabling it to be taken without water and dissolving easily in the mouth. CMG Pharmaceutical said that Mezofy’s approval is significant because it was approved as an incrementally modified drug (IMD) whose chemical structure or formulation is altered from an already approved drug. IMDs are eligible for higher prices compared to generic drugs and can be marketed under brand