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Bausch & Lomb ZyLET "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bausch & Lomb continues to expect a second-half 2004 approval of ZyLET (loteprednol etabonate 0.5%/tobramycin 0.3%) following a July "approvable" letter. The ophthalmic combination product "is aimed at treating patients with steroid-responsive inflammatory ocular conditions who have or are at risk of developing superficial bacterial ocular infections," former marketing partner Pharmos said. The ZyLET NDA was submitted in September 2003...
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