Mezofy (aripiprazole OTF) / CMG Pharma - LARVOL DELTA

CMG Pharmaceutical gains FDA approval for film-type antipsychotic (The Korea Herald) - "CMG Pharmaceutical, an affiliate of Cha Biotech, announced Wednesday that its oral film-type antipsychotic drug has received approval from the US Food and Drug Administration....According to the company, its newly approved schizophrenia treatment, Mezofy, marks the fourth time a Korean pharmaceutical company has received FDA approval for an incrementally modified drug, and the first time based specifically on a formulation change....It plans to team up with a local retail partner in the latter half of this year, with Mezofy’s US launch expected in the first half of 2026."

FDA approval • Launch US • Schizophrenia

Bioequivalence of Aripiprazole Oral Soluble Films and Orally Disintegrating Tablets in Healthy Participants: A Crossover Study. (PubMed, Clin Transl Sci) - "Both formulations were well-tolerated. In conclusion, aripiprazole OSF and ODT reached bioequivalence, and aripiprazole OSF demonstrates significant potential for application in the treatment of psychiatric disorders."

Clinical • Journal • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

S. Korea’s CMG Pharma files sales approval for schizophrenia drug in U.S. (Pulse News) - "South Korea’s CMG Pharmaceutical Co. has filed an application with the U.S. Federal Drug Administration (FDA) to market its schizophrenia medication Depipzo (aripiprazole)....The company hopes to start selling the schizophrenia in the U.S. as early as in the second half of this year....Lee Ju-hyung, chief executive officer of CMG Pharmaceutical, said the company already has launched a process to select local sales partner to kick off sales as soon as it gains FDA’s approval. The company also plans to roll out the schizophrenia drug in other markets including Europe."

Launch • NDA