Saturday, August 24, 2019

Saturday, August 24, 2019

LANNETT COMPANY, INC.: FDA Clears Path For The Continuing Review Of Lannett Company's New Drug Application


Lannett Company, Inc.issued the following announcement on July 3.

Lannett Company, Inc. (NYSE: LCI) 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."

About Lannett Company, Inc.:

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at www.lannett.com.  

Original source can be found here.

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