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Otiprio FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

FDA Approved: Yes (First approved December 10, 2015)
Brand name: Otiprio
Generic name: ciprofloxacin
Dosage form: Otic Suspension
Previous Name: AuriPro
Company: Otonomy, Inc.
Treatment for: Tympanostomy Tube Placement Surgery; Acute Otitis Externa

Otiprio (ciprofloxacin otic suspension) is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery, and for the treatment of acute otitis externa due to Pseudomonas aeruginosa and Staphylococcus aureus.

Development timeline for Otiprio

Mar  2, 2018Approval Otonomy Announces FDA Approval of Otiprio (ciprofloxacin otic suspension) for Acute Otitis Externa
Dec 11, 2015Approval FDA Approves Otiprio (ciprofloxacin otic suspension) for the Treatment of Pediatric Patients Undergoing Tympanostomy Tube Placement Surgery
Apr 28, 2015Otonomy Announces FDA Acceptance of AuriPro New Drug Application
Feb 26, 2015Otonomy Submits New Drug Application to the FDA for AuriPro

Further information

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