FDA accepts approval application for lurasidone

FORT LEE, N.J. The Food and Drug Administration has accepted an approval application for a new drug to treat schizophrenia.

Dainippon Sumitomo Pharma America announced Wednesday that the agency agreed to review the drug lurasidone. The application, submitted Dec. 30, follows more than 40 clinical studies of more than 2,500 patients.

“We are pleased that the lurasidone [application] has been accepted for review by the FDA,” Dainippon president and CEO Masayo Tada said. “We look forward to the potential lurasidone may bring as it represents our commitment to developing therapies that provide clear value to patients and healthcare professionals.”

Login or Register to post a comment.