US FDA Schedules Final Label Review of Bausch&Lomb Technolas

Bausch & Lomb (NYSE:BOL) and the U.S. Food and Drug Administration are scheduled to meet next week to finalize the labeling for the Bausch & Lomb Technolas 217A Excimer Laser System's expanded indication to treat hyperopia with or without astigmatism. The FDA's scientific review of the system is now complete. Bausch & Lomb has been actively working with the agency to identify and resolve all labeling changes to be included in the final package. Following the labeling review to finalize changes, the FDA will be in the position to issue the final approval order for the expanded treatment indication of hyperopia with and without astigmatism.

(Source: APBiscom)