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Otovel Approval History

  • FDA approved: Yes (First approved April 29th, 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 History and FDA Approval Process for Otovel

DateArticle
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

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