CetraxalTreatment for Otitis Externa
Update: Cetraxal Now FDA Approved - May 1, 2009
Salvat Announces the FDA Acceptance of NDA for its Cetraxal Otic Solution
BARCELONA, Spain, September 14, 2005 - Salvat announced that the New Drug Application (NDA) for its Cetraxal Otic -ciprofloxacin otic- 0.2% Solution, for the Treatment of External Otitis has been accepted for review by the U.S. Food and Drug Administration (FDA).
Cetraxal Otic, in a single dispensing container, will be the only ciprofloxacin alone solution approved by the FDA for the indication of external otitis, providing high efficacy and more convenience without the risk of steroids, aminoglycosides and preservatives.
"We are very pleased to have passed another hurdle on our way to introduce Cetraxal otic in the US. Cetraxal otic combines 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. Discussions with commercial partners confirm us the great interest for Cetraxal otic in the US market. We are confident that the right partner will help us to bring the benefits of this new product to a great number of patients," said Jordi Julve, COO of Salvat.
Posted: September 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 Files NDA for its Cetraxal Otic - Ciprofloxacin Otic- 0.2% Solution, for the Treatment of External Otitis - June 10, 2005
- Salvat Seeks FDA Approval for its Cetraxal Otic (Ciprofloxacin Otic) 0.2% Solution, for the Treatment of External Otitis - April 18, 2005