FDA Clears Path For Continuing Review Of Lannett New Drug Application

Lannett Company, Inc. (NYSE: LCI) today commented on the U.S. Food and Drug Administration‘s (FDA) denial of a Citizen Petition submitted by Genus Lifesciences requesting that the FDA refuse to accept any submissions related to Lannett’s 505(b)(2) New Drug Application (NDA) for Cocaine Hydrochloride Topical Solution, 4% and 10%.

“We are pleased with the FDA’s decision, which affirmed our belief that the regulatory review of our NDA can continue,” said Tim Crew, chief executive officer of Lannett. “We believe we have addressed and responded to all comments in the FDA Complete Response Letter, including conducting a QT prolongation study, and we believe we will receive approval by early 2020.”

https://www.biospace.com/article/releases/fda-clears-path-for-the-continuing-review-of-lannett-company-s-new-drug-application/