Bausch & Lomb ZyLET Clears FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Loteprednol/tobramycin ophthalmic will be marketed by sales force that had been promoting the conjunctivitis agent Optivar.
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Bausch & Lomb's combination ophthalmic ZyLET received FDA approval Dec. 14. The product is indicated for steroid-responsive, inflammatory ocular conditions for which a corticosteroid is indicated and where superficial, bacterial ocular infection or a risk of bacterial ocular infection exists. ZyLET (loteprednol 0.5%/tobramycin 0.3% ophthalmic suspension) will be promoted by the B&L sales reps who were detailing the conjunctivitis agent Optivar (1 (Also see "B&L Will Shift Optivar Reps To Anticipated New Product Launches In 2005" - Pink Sheet, 8 Dec, 2004.)) MedPointe ended its co-promotion agreement on Optivar (azelastine hydrochloride ophthalmic solution 0.05%) to bring promotion in-house. The ZyLET NDA (50-804) was submitted in September 2003 and received an "approvable" letter in July (2 (Also see "Bausch & Lomb Ophthalmic ZyLET Is “Approvable” At FDA" - Pink Sheet, 9 Aug, 2004.)). - M. Nielsen Hobbs |