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B&L blindsided

This article was originally published in The Gray Sheet

Executive Summary

Diabetic macular edema indication filing for Retisert drug-delivery implant will be pushed back up to three years, due to the agency's request for 12-month safety data from additional patients implanted with the device, Bausch & Lomb says May 7. The DME new drug application (NDA) filing delay marks the second regulatory setback to the firm's drug-delivery program, following Retisert's one-year NDA submission hold-up for treatment of posterior uveitis. That delay occurred because of a similar request for expanded clinical data (1"The Gray Sheet" March 10, 2003, p. 25)...
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