BARCELONA, Spain, November 5 SALVAT announced today thesubmission of the response to the FDA Approvable Letter for CETRAXAL(R)(Ciprofloxacin 0.2% Otic Solution in Single Dose Containers). In anApprovable Letter received on April 6, 2006, the FDA requested additionaldata with respect to chemistry, manufacturing, and controls (CMC).
SALVAT expects the FDA to classify the complete response as a Class 2resubmission, under which the FDA will seek to complete its review of theresubmission within 180 days from the time of resubmission. SALVAT believesthat the response submitted today to the FDA fully addresses the Agencyrequest.
The Approvable Letter did not raise any questions related to efficacy orsafety of CETRAXAL(R) Otic Solution.
SALVAT is currently evaluating potential commercial partners in theUnited States to licensing out CETRAXAL(R) and expects to launch it duringthe second quarter of 2009, subject to FDA approval.
The NDA for CETRAXAL(R) seeks marketing approval for the treatment ofAcute Otitis Externa in pediatric (aged 1 year and older) and adult patients.
CETRAXAL(R) is a Ciprofloxacin 0.2% Otic Solution for the treatment ofAcute 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% inthe 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 whichmake easy to ensure correct dosing and to place drops into the ear.
SALVAT is an independent, privately owned, Spanish pharmaceutical groupclosely identified with technological innovation and strongly committed toR&D. The most advanced NCE is SVT-40776 for the treatment of OveractiveBladder, which has recently finished phase II. In 2007 SALVAT's products weredistributed in more than 30 countries all over the world in collaborationwith well reputed pharmaceutical partners. SALVAT is working to strengthenits international presence by licensing its own developments and byemphasizing collaborations regarding its pipeline products.Contact: Cristina Viayna, Business Development & Licensing, firstname.lastname@example.org , Phone: +1-305-774-9727. http://www.salvatbiotech.com