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news.Valeant Pharmaceuticals International has relaunched its generic ofloxacin otic solution to treat bacterial ear infections.
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The product was temporarily discontinued in April 2015 due to an issue concerning the active pharmaceutical ingredient supplier, which has been resolved.
Ofloxacin otic is a quinolone antibiotic solution used to treat outer ear infections in adults and children, chronic middle ear infections in adults and children with perforated eardrums, and acute middle ear infections in children with ear tubes. The product targets bacteria that cause the infection.
"We are pleased to relaunch this important product that improves the lives of a large population of children and adults who suffer from ear infections," said Joseph C. Papa, chairman and chief executive officer of Valeant.
"Given the limited number of alternative products on the market, our team invested significant time and resources working with our active pharmaceutical ingredient supplier and the FDA to resolve this issue as quickly as possible. This relaunch demonstrates the strength of our generic portfolio, as well as our dedication to delivering effective and affordable treatments to patients."
The ofloxacin otic solution began shipping to customers on August 1, 2016 and will be available at most major retailers across the U.S.
About Ofloxacin Otic
Ofloxacin otic solution 0.3% is indicated for the treatment of infections in the following specific conditions:
Otitis Externa in adults and pediatric patients > 6 months of age due to E. coli, Pseudomonasaeruginosa, and Staph. aureus.
Chronic Suppurative Otitis Media in patients > 12 years of age with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staph. Aureus.
Acute Otitis Media in pediatric patients > 1year of age with tympanostomy tubes due to Haemophilus influenza, Moraxella catarrhalis, Pseudomonas aeruginosa, Staph. Aureus and Strep. Pneumoniae.
Safety Information
Adverse reactions in patients with non-intact tympanic membranes include diarrhea, nausea, vomiting, dry mouth, headache, vertigo, otorrhagia, tinnitus and fever. Prolonged use may result in over-growth of nonsuceptible organisms, including fungi. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolones.