Ciprofloxacin intratympanic - Otonomy

Drug Profile

Ciprofloxacin intratympanic - Otonomy

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

Latest Information Update: 11 Aug 2017

Price : *
* Final gross price and currency may vary according to local VAT and billing address.

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.

    No
  • 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
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top