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FDA ANNOUNCES NEW LABELING CHANGES FOR REGRANEX

The U.S. Department of Health & Human Services' Food & Drug Administration issued the following press release:

The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

The WARNINGS section of the product has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for the revised label. These data come from a retrospective study that compared ...

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