Bausch & Lomb
This article was originally published in The Gray Sheet
Executive Summary
Delaware lower court injunction against U.S. manufacture and sale of PureVision continuous-wear contact lenses is amended to allow distribution of the lenses to participants in the firm's 5,000-patient post-approval study. FDA requires a post-approval study for all manufacturers of 30-day continuous-wear contact lenses; B&L's study commenced in March 2002. The firm reports that it has completed the transfer of PureVision manufacturing from its Rochester, N.Y. plant to Ireland. B&L filed an appeal with the D.C. federal appeals court in June 2002...