FDA Clears Path For The Continuing Review Of Lannett Company’s New Drug Application

July 3, 2019 |

2 min read

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

PHILADELPHIA, July 3, 2019 /PRNewswire/ -- 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%.

Lannett Logo (PRNewsFoto/Lannett Company, Inc.)

“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.

This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, the timing and outcome of the U.S. Food and Drug Administration (FDA) review of the Cocaine Hydrochloride NDA, FDA approval of the Cocaine Hydrochloride NDA and future market acceptance and revenue for Cocaine Hydrochloride; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any, and market acceptance of and continued demand for Lannett’s products, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company’s Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company’s judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.