SK Biopharmaceuticals has announced that its anti-epileptic drug has been granted approval by the U.S. Food and Drug Administration.
Its XCOPRI tablets have been approved to treat partial-onset seizures in adults.
This is the first time a South Korean pharmaceutical company has independently earned FDA approval without a partnership or license.
In a statement, SK Biopharmaceuticals said the FDA approval is a major step toward its goal of becoming a fully integrated global pharmaceutical company that can deliver new treatment options for epilepsy and the central nervous system.
XCOPRI is expected to be available in the United States in the second quarter of 2020.