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Otovel FDA Approval History

FDA Approved: Yes (First approved April 29, 2016)
Brand name: Otovel
Generic name: ciprofloxacin and fluocinolone acetonide
Dosage form: Otic Solution
Company: Laboratorios Salvat S.A. and Arbor Pharmaceuticals, LLC
Treatment for: Acute Otitis Media with Tympanostomy Tubes

Otovel otic solution (ciprofloxacin and fluocinolone acetonide) is a fluoroquinolone antibacterial and corticosteroid combination indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients.

Otovel otic solution is administered into the affected ear canal via a single-use vial (0.25 mL) twice daily for seven days. The most commonly reported side effects include ear discharge, infection, swelling, itching, scar tissue, and problems with balance.

Development timeline for Otovel

Aug 29, 2016Approval Laboratorios Salvat S.A. and Arbor Pharmaceuticals, LLC Announce the Launch of Otovel (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) Otic Solution

Further information

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