CetraxalTreatment for Otitis Externa
Update: Cetraxal Now FDA Approved - May 1, 2009
Salvat Seeks FDA Approval for its Cetraxal Otic (Ciprofloxacin Otic) 0.2% Solution, for the Treatment of External Otitis
BARCELONA, Spain, April 18, 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. 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: April 2005
- 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 Files NDA for its Cetraxal Otic - Ciprofloxacin Otic- 0.2% Solution, for the Treatment of External Otitis - June 10, 2005