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# FDA Accepts Lannett NDA for Topical Anesthetic
- URL: https://www.fdaweb.com/fda-accepts-lannett-nda-for-topical-anesthetic/
- Published: 2017-12-01T12:00:00.000Z
- Updated: 2026-09-14T23:04:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140248

FDA has accepted for review a Lannett 505(b)(2) NDA for Numbrino (cocaine hydrochloride) topical solution, 4% and 10%, indicated for use as a local topical anesthetic. FDA has assigned a user fee review action target date of 7/21/2018\. The submission is based on data from two Phase 3, randomized, double-blind, placebo-controlled, multicenter studies in several hundred patients, as well as a Phase 1 pharmacokinetic study, according to the company.