FDA Approves Otiprio
December 14, 2015 – The U.S. Food and Drug Administration (FDA) approved Otiprio (ciprofloxacin otic suspension, 6%) for the treatment of patients with bilateral otitis media (ear infections) with effusions undergoing tympanostomy tube, or ear tube placement. Otiprio, manufactured by Otonomy, is a single-dose, physician administered medication with a recommended dosing of 0.1mL (6mg) intratympanic (middle ear) administration into each affected ear, after suctioning of the middle ear effusion. Otiprio contains ciprofloxacin microparticles that are slowly released after administration. At room temperature, Otiprio is a suspension, but turns into a gel when warmed with a proprietary formulation. Results from clinical trials showed fewer treatment failures with Otiprio compared to when tube placement was used alone. Launching for Otiprio is anticipated for early 2016.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.