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# Lannett Cocaine Nasal Anesthetic Approved
- URL: https://www.fdaweb.com/lannett-cocaine-nasal-anesthetic-approved/
- Published: 2020-01-15T12:00:00.000Z
- Updated: 2026-09-14T15:58:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145855

FDA has approved a Lannett Co. NDA for cocaine hydrochloride nasal solution 4% (40 mg/mL), the company’s first branded local anesthetic product indicated for the introduction of local anesthesia in the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults. The 505(b)(2) submission was supported by two Phase 3, randomized, double-blind, placebo-controlled, multicenter studies in several hundred patients, as well as a Phase 1 pharmacokinetic study.