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Egrifta Approval: FDA Balanced Modest Efficacy, Off-Label Use Potential With Unmet Medical Need

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The approval of Theratechnologies’ HIV lipodystrophy treatment Egrifta (tesamorelin) shows how much FDA can be swayed by unmet need, even where the product has limited efficacy in a narrow population and substantial potential for off-label use.
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