Cetraxal
Generic name: ciprofloxacin otic
Treatment for: Otitis Externa
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.
About SALVAT
SALVAT is an independent, privately owned, Spanish pharmaceutical group closely identified with technological innovation and strongly committed to R&D.
Posted: June 2005
Related articles
- FDA Approves Cetraxal Otic Solution - May 1, 2009
- Salvat Announces Submission of Complete Response to FDA Approvable Letter for Cetraxal - November 6, 2008
- Salvat Announces the FDA Acceptance of NDA for its Cetraxal Otic Solution - September 14, 2005
- Salvat Seeks FDA Approval for its Cetraxal Otic (Ciprofloxacin Otic) 0.2% Solution, for the Treatment of External Otitis - April 18, 2005
Cetraxal (ciprofloxacin otic) FDA Approval History
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