SK Biopharmaceuticals said that it has completed all the regulatory approval processes to launch Xcopri, a treatment for partial-onset seizures in adults, in the U.S., after receiving a schedule V classification from the Drug Enforcement Administration.
Central nervous system drugs are subject to the classification from the DEA, which consists of five levels -- schedules I to V -- by evaluating the drug's medical use and potential for abuse and dependence, after receiving approval from the Food and Drug Administration (FDA). The classification determines the level of drug management.
Xcopri received a schedule V classification, which means that the drug is least likely to be abused.
Xcopri is the first epilepsy drug independently developed by a Korean company, beginning from candidate discovery to FDA approval. The company plans to commercialize the product through SK Life Sciences, its U.S. subsidiary.
"After completing the DEA's evaluation, our company has completed the final step of the regulatory approval process to launch Xcopri in the U.S.," SK Biopharmaceuticals CEO Cho Jeong-woo said. "We are moving forward to launch XCOPRI as planned in the second quarter of 2020 and remain steadfast in our commitment to addressing unmet needs for patients with epilepsy."
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