With a new drug application (NDA) filed at the FDA, SK Life Science Inc., part of one of South Korea's largest conglomerates, is taking a big step closer to gaining a foothold in the U.S. epilepsy treatment market. Now awaiting a Nov. 21 PDUFA date, the company's candidate cenobamate is poised to become its first-ever independent biopharma success in America. A commercial launch for the medicine, which would be initially marketed as an adjunctive therapy, could arrive as early as the first quarter of 2020. An approval would be followed by a 90-day DEA review for scheduling.