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Approvable Letter Issued for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension
ISELIN, N.J., Aug. 9 /PRNewswire-FirstCall/ -- Pharmos Corporation former marketing partner, Bausch & Lomb, has received from the U.S. Food and Drug Agency (FDA) an approvable letter for ZyLET, the NDA for which was filed by Bausch & Lomb last year. The first disclosure of this event was made by Bausch & Lomb in a Form 10Q filed on August 3, 2004, in which Bausch & Lomb also indicates it continues to target approval of ZyLET in the second half of 2004. Details of the approvable letter have not been publicly disclosed by Bausch & Lomb.
In 2001, Bausch & Lomb acquired the rights to the loteprednol etabonate ophthalmic business of Pharmos Corporation. Bausch & Lomb will pay Pharmos a milestone payment upon approval to market the product.
ZyLET is a loteprednol etabonate and tobramycin ophthalmic suspension. The combination therapy is aimed at treating patients with steroid-responsive inflammatory ocular conditions who have or are at risk of developing superficial bacterial ocular infections.