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About the FDA Approved Listings

Drugs Approved by the FDA

Drug Name: Floxin otic

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Daiichi Pharmaceutical
Approval Status: Approved December 1997
Treatment for: otitis media (ear infections)

General Information

Floxin otic (ofloxacin otic solution) has been approved for the treatment of various forms of otitis media in pediatric and adult patient populations. Labeling directs otitis externa pediatric patients, one to 12 years old, to take five drops instilled into the affected ear twice daily for ten days. Patients 12 years and older should take ten drops twice daily for ten days.

Side Effects

Side effects reported during clinical trials included pruritis, application site reaction, dizziness, earache, taste perversion, and vertigo.


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Drug listing last updated on June 20, 2008

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