Article
Anesthetic Nasal Solution Granted FDA Approval
The nasal solution is a local anesthetic indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries.
Officials with the FDA have approved Lannett Company's New Drug Application for cocaine hydrochloride (HCI) nasal solution, 4% (Numbrino).
The nasal solution is a local anesthetic indicated for mucous membranes with diagnostic procedures and surgeries, on or through the naval cavities of adults, according to Lannett.
The NDA submission was supported by a pair of phase 3, placebo-controlled, multicenter studies in several patients, as well as a phase 1 pharmacokinetic study.
REFERENCE
Lannett announces FDA approval of NDA for branded anesthetic product, cocaine hydrochloride nasal solution, 4% [news release]. Philadelphia, PA; Lannett: January 13, 2020. https://lannett.investorroom.com/2020-01-13-Lannett-Announces-FDA-Approval-Of-NDA-For-Branded-Anesthetic-Product-Cocaine-Hydrochloride-Nasal-Solution-4. Accessed January 14, 2020.
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