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 pharmaceutical company said Thursday the U.S. FDA has notified of receiving its final application for marketing Depipzo in the U.S. last week. The company hopes to start selling the schizophrenia in the U.S. as early as in the second half of this year.
Depipzo is the world’s first oral dissolving film type drug for treating schizophrenia, according to the company. It used proprietary technology to make it easier to take by removing bitterness and also minimize deformation, said the company.
The U.S. is the world’s biggest schizophrenia drug market with annual sales estimated at 5 trillion won ($4.3 billion), according to market researcher Data Monitor. The market will become even bigger when the use of aripiprazole will be allowed to treat other mental illness such as depression, bipolar disorder, and tic disorder.
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.
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