Ciprofloxacin intratympanic - Otonomy

Drug Profile

Ciprofloxacin intratympanic - Otonomy

Alternative Names: AuriPro™; Ciprofloxacin otic suspension - Otonomy; OTIPRIO; OTO-201

Latest Information Update: 11 Aug 2017

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At a glance

  • Originator Otonomy
  • Class Antibacterials; Cyclopropanes; Fluoroquinolones; Piperazines; Small molecules
  • Mechanism of Action DNA gyrase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Otitis media
  • Preregistration Otitis externa

Most Recent Events

  • 04 Aug 2017 Otonomy plans to initiate a pivotal phase III trial in paediatric patients with Acute otitis media with tympanostomy tubes (AOMT)
  • 18 Jul 2017 FDA assigns PDUFA action date of 02/03/2018 for ciprofloxacin intratympanic for Otitis externa (In adolescents, In children, In the elderly, In infants, In adults)
  • 18 Jul 2017 US FDA accepts sNDA for ciprofloxacin intratympanic for Otitis externa for review
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