New Indication for Otiprio
March 2, 2018 – The U.S. FDA has approved a new indication for Otonomy’s Otiprio® (ciprofloxacin otic suspension 6%) to treat patients six months of age and up who have acute otitis externa (AOE) caused by Pseudomonas aeruginosa and Staphylococcus aureus infection.
Better known by the name swimmer’s ear, AOE affects an estimated 4 million people in the United States every year. Signs and symptoms include inflammation, itching, redness, and swelling of the ear canal. Typically, the condition occurs after swimming or following trauma from cleaning the ear canal using inappropriate methods.
Otiprio, an antibiotic, is a one-time treatment administered by healthcare providers. Recommended dosing is one drop in each affected ear. Other existing topical treatments usually require several applications per day, over a period of up to 10 days.
First approved in 1987, Otiprio is also indicated for use during implantation of pressure equalizing tubes in the ear for patients who are six months and older and have bilateral otitis media with effusion.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.