November 05, 2003
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Combo anti-inflammatory, anti-infective application accepted by FDA
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The Food and Drug Administration has accepted a New Drug Application for loteprednol etabonate and tobramycin ophthalmic suspension for the treatment of inflammation and infection, the drug’s marketers announced in a joint press release.
Bausch & Lomb and Pharmos Corp. submitted the NDA for the combination therapy, aimed at treating patients with steroid-responsive inflammatory ocular conditions who have or are at risk of developing superficial bacterial ocular infections.
In 2001, Bausch & Lomb acquired the rights to the loteprednol etabonate ophthalmic business of Pharmos Corp, the press release noted. Bausch & Lomb has indicated that, pending FDA review, it expects to introduce the new combination medication in 2004.