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| |  FDA Approves Quixin (levofloxacin) For Bacterial Conjunctivitis OSAKA, JAPAN -- August 21, 2000 -- Santen Pharmaceutical Co., Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved its new ocular anti-infective medication, Quixin™ (levofloxacin ophthalmic solution) 0.5%, indicated for the treatment of bacterial conjunctivitis. The New Drug Application (NDA) was submitted to the FDA on March 1, 2000 by Santen Incorporated, Santen's Napa, California based subsidiary. The company anticipates the launch of Quixin in the U.S. ophthalmic market by late 2000. Quixin is a sterile topical ophthalmic solution containing 0.5% levofloxacin, a potent, broad spectrum fluoroquinolone. Levofloxacin's higher solubility, at neutral pH, allows Quixin to be formulated at a higher concentration of active drug compared to other currently marketed ophthalmic fluoroquinolones (0.5% vs. 0.3%). Bacterial conjunctivitis, commonly known as "pink eye," is a prevalent condition characterized by redness of the eye, mucous discharge, tearing, irritation and sensitivity to light. Quixin has shown outstanding efficacy against a wide range of causative organisms, including the most common gram-positive and gram-negative pathogens, Staphylococcus aureus, Streptococcus pneumoniae and Haemophilus influenzae. In controlled clinical trials in which bacterial conjunctivitis patients were dosed for 5 days, Quixin demonstrated excellent clinical and microbial efficacy; 79 percent of patients experienced clinical cure and microbial eradication rates were 90 percent. With an active drug concentration of 0.5% and powerful bactericidal properties, Quixin topical therapy rapidly resolves the signs and symptoms of bacterial conjunctivitis. Related Link: Santen Pharmaceutical Co., Ltd.
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