FDA Accepts Lannett NDA for Cocaine Hydrochloride Topical Solution for Standard Review
4 December 2017 - - Philadelphia, Pennsylvania-based generic pharmaceuticals company Lannett Company, Inc.'s (NYSE: LCI) 505(b) (2) new drug application for Cocaine Hydrochloride Topical Solution, 4% and 10%, with a proposed trade name of Numbrino, has been accepted for filing with standard review by the US Food and Drug Administration, the company said.
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 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.
Lannett Co, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.