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Treatment for Otitis Externa

Update: Cetraxal Now FDA Approved - May 1, 2009

SALVAT Files NDA for its Cetraxal Otic - Ciprofloxacin Otic- 0.2% Solution, for the Treatment of External Otitis

BARCELONA, Spain, June 10, 2005 -- SALVAT today announced that it has submitted a new drug application for 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 phase III clinical trial, which is the basis for their application.

"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 pediatric population.

We are convinced that finding the right commercial partner in the US will help us to bring the benefits of this new product to a great number of patients" said Jordi Julve, COO of SALVAT.

SALVAT is an independent, privately owned, Spanish pharmaceutical group closely identified with technological innovation and strongly committed to R&D.

Posted: June 2005

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