PHILADELPHIA, Dec. 1, 2017 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that the 505(b)(2) New Drug Application (NDA) for Cocaine Hydrochloride (HCl) Topical Solution, 4% and 10%, with a proposed trade name of Numbrino^™, has been accepted for filing with standard review by the U.S. Food and Drug Administration (FDA).  Cocaine HCl Topical Solution is a proprietary local topical anesthetic.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 21, 2018, ten months from the official NDA submission date.  The user fee goal date (PDUFA goal date) is the date by which an FDA action is due on a marketing application.

"The FDA's acceptance of the Cocaine HCl Topical Solution NDA is an important step in the FDA review process, indicating that the application is sufficiently complete to permit a substantive review," said Arthur Bedrosian, chief executive officer of Lannett.  "Cocaine Hydrochloride Topical Solution represents an opportunity to bring a new local anesthetic to the medical community and patients.  We are currently seeking an approval for the product with a nasal indication and, once approved, plan to pursue additional indications.  Our market research suggests that the product may have broad applicability across a number of medical specialties, including Ears, Nose and Throat (ENT), Dermatologists, Obstetrics and Gynecology (OB-GYNs), Ophthalmologists, Emergency-Room (ER) physicians, oral surgeons, Proctologists, Veterinarians, Neurologists, Urologists, pain specialists, Oncologists, Hematologists and Podiatrists. 

"This filing is the company's first NDA submission to include full clinical trial studies.  An approval of the NDA has the potential to transform the company into a formidable force in both the generic and branded drug industries.  I am extremely proud of this accomplishment and of our entire team for their efforts."

The 505(b)(2) NDA submission is supported by two Phase III, randomized, double-blind, placebo-controlled, multicenter studies in several hundred patients, as well as a Phase I pharmacokinetic study.

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.

 

SOURCE Lannett Company, Inc.