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FDA Saga To Block Sage Pharmaceuticals Shows Enforcement Challenges

This article was originally published in The Tan Sheet

Executive Summary

After at least eight warning letters and a previous injunction over a decade failed to stop Sage Pharmaceuticals from allegedly making and distributing misbranded and unapproved OTC and Rx drugs, FDA is taking another run at the firm via a DoJ suit. The firm’s disregard of previous warnings underscores the challenges FDA must overcome to become an effective enforcer.

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