SALVAT Announces the FDA Acceptance of NDA for its CETRAXAL Otic Solution.BARCELONA, Spain -- SALVAT announced that the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for its CETRAXAL Otic otic (ot´ik) auditory (1). o·tic adj. Of, relating to, or located near the ear; auricular. Otic Pertaining to the ear. -ciprofloxacin otic- 0.2% Solution, for the Treatment of External Otitis otitis Inflammation of the ear. Otitis externa is dermatitis, usually bacterial, of the auditory canal and sometimes the external ear. It can cause a foul discharge, pain, fever, and sporadic deafness. has been accepted for review by the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). 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 pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. 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. About SALVAT SALVAT is an independent, privately owned, Spanish pharmaceutical group closely identified with technological innovation and strongly committed to R&D. |
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