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Ciba Vision Voltaren

Executive Summary

The claim that Voltaren (diclofenac ophthalmic solution) achieves "complete and normal corneal re-epithelialization equivalent to placebo" is misleading because Voltaren and other non-steroidal anti-inflammatory drugs delay healing, a July 16 FDA letter regarding Ciba Vision's April 15 advertisement in Ocular Surgery News says. FDA objects to the word "equivalent" because it would imply a similar period of recovery. A claim that Voltaren "significantly reduces oral narcotic use" also drew attention from FDA because there are no clinical data regarding the use of opiates with Voltaren
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PS032619

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