November 5, 2008
SALVAT Announces Submission of Complete Response to FDA Approvable Letter for CETRAXAL(R)
SALVAT announced today the submission of the response to the FDA Approvable Letter for CETRAXAL(R) (Ciprofloxacin 0.2% Otic Solution in Single Dose Containers). In an Approvable Letter received on April 6, 2006, the FDA requested additional data with respect to chemistry, manufacturing, and controls (CMC).
SALVAT expects the FDA to classify the complete response as a Class 2 resubmission, under which the FDA will seek to complete its review of the resubmission within 180 days from the time of resubmission. SALVAT believes that the response submitted today to the FDA fully addresses the Agency request.The Approvable Letter did not raise any questions related to efficacy or safety of CETRAXAL(R) Otic Solution.
SALVAT is currently evaluating potential commercial partners in the United States to licensing out CETRAXAL(R) and expects to launch it during the second quarter of 2009, subject to FDA approval.
The NDA for CETRAXAL(R) seeks marketing approval for the treatment of Acute Otitis Externa in pediatric (aged 1 year and older) and adult patients.
CETRAXAL(R) is a Ciprofloxacin 0.2% Otic Solution for the treatment of Acute Otitis Externa. In a phase III clinical trial compared to Neomycin, Polymyxin B sulfates and Hydrocortisone otic solution (NPH), CETRAXAL(R) obtained a clinical cure rate of 93.9% in pediatric patients (vs. 76.0% in the NPH group) and resolved or improved otalgia in 99.2% of the patients. There were no adverse reactions with an incidence higher than 1%. CETRAXAL(R) will be available in sterile, preservative-free single-dose containers which make easy to ensure correct dosing and to place drops into the ear.
SALVAT is an independent, privately owned, Spanish pharmaceutical group closely identified with technological innovation and strongly committed to R&D. The most advanced NCE is SVT-40776 for the treatment of Overactive Bladder, which has recently finished phase II. In 2007 SALVAT's products were distributed in more than 30 countries all over the world in collaboration with well reputed pharmaceutical partners. SALVAT is working to strengthen its international presence by licensing its own developments and by emphasizing collaborations regarding its pipeline products.