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Phase III Topical Application of Cocaine HCl 4% Solution on Safety/Efficacy & Cocaine HCl 4% & 10% Solution on Safety in Local Anesthesia for Diagnostic Procedures & Surgeries on or Through Accessible Mucous Membranes of the Nasal Cavities

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Trial Profile

Phase III Topical Application of Cocaine HCl 4% Solution on Safety/Efficacy & Cocaine HCl 4% & 10% Solution on Safety in Local Anesthesia for Diagnostic Procedures & Surgeries on or Through Accessible Mucous Membranes of the Nasal Cavities

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jan 2020

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At a glance

  • Drugs Cocaine (Primary)
  • Indications Intraoperative pain; Procedural pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Lannett

Most Recent Events

  • 13 Jan 2020 According to a Lannett media release, U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted under the 505(b)(2) regulatory pathway, for Cocaine Hydrochloride (HCl) Nasal Solution 4% (40 mg/mL), the company's branded local anesthetic product.The submission was supported by two Phase III s well as a Phase I pharmacokinetic study.
  • 01 Dec 2017 According to a Lannett media release, this FDA acceptance is based, on the data of this trial and other phase III trial (227076) along with the data of a pharmacokinetic phase 1 trial.
  • 01 Dec 2017 According to a Lannett media release, the U.S. Food and Drug Administration (FDA) has accepted a 505(b)(2) New Drug Application (NDA) filing for Cocaine Hydrochloride (HCl) Topical Solution, 4% and 10%, with a proposed trade name of Numbrino™, for the introduction of local (topical) anesthesia for diagnostic procedures and surgeries on or through the accessible mucous membranes of the nasal cavities. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 21, 2018.

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