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CMG Pharma's Mezofy gets first U.S. FDA approval for changed form for Korea

Published: 16 Apr. 2025, 16:35

YOON SO-YEON
[email protected]

CMG Pharmaceutical logo [CMG PHARMACEUTICAL]

Mezofy, an oral film-type medication for treating schizophrenia developed by CMG Pharmaceutical, received approval from the U.S. Food and Drug Administration (FDA), the CHA Biotech subsidiary said Wednesday.

Mezofy is an antipsychotic that was previously made in the form of pills. But since patients suffering from schizophrenia often have difficulty swallowing pills or keeping to a set time schedule, Mezofy was made in a version that can melt inside the mouth without water.

The drug is the fourth Korean incrementally modified drug (IMD) to receive FDA approval and the first ever to get approval after a change in the medication form. IMDs allow pharmaceuticals to sell the products under the brand name, not the ingredient, making marketing much more effective for the developer.

"Until now, getting FDA approval for an IMD was considered the prize of large pharmaceutical companies due to the high entry barriers," said CMG Pharmaceutical CEO Lee Joo-hyung.

"With its experience in getting approval for a diverse range of pharmaceutical products and close partnerships with global companies, CMG Pharmaceutical has achieved the monumental feat of receiving approval for an IMD as a mid-sized company."

BY YOON SO-YEON [[email protected]]