SALVAT Seeks FDA Approval For its CETRAXAL Otic (ciprofloxacin otic) 0.2% Solution, For The Treatment Of External Otitis
10/19/2005 5:10:58 PM
BARCELONA, Spain--(BUSINESS WIRE)--April 26, 2005--SALVAT announce plans to file their CETRAXAL Otic solution, with its convenient, single-dispensing container (SDC) format, with the FDA.
The efficacy and safety of the treatment has been assessed in a 630 patient clinical trial, which will be the basis for their application in the 2nd quarter of 2005.
"We combined the advantages of a proven, effective antibiotic with a simple, accurate form of administration. The idea behind our product is to reduce unnecessary ingredients thus avoiding unexpected adverse reactions, especially problematic in the paediatric population.
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