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Late last week, the FDA filed a short post-argument submission with the Third Circuit in Colacicco, which the parties recently received. Here’s a copy. It’s only a couple of pages. The submission has three purposes: (1) It provides the court with a copy of the brief that the agency recently filed with the Supreme Court in the Wyeth v. Levine case. We’ve already gone over that and we liked it, so we’re pleased to see the Third Circuit get a copy. (2) The agency goes out of its way to mention the argument that manufacturers only have the right to make label changes prior to FDA approval where those changes involve “material new information.” That presaged the FDA’s latest regulatory initiative, and was also the subject of a post here last year. (3) The FDA also makes the point that it has the power to reject this kind of label change the same as it can reject any other.