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Egrifta Post-marketing Study On Diabetic Retinopathy Will Include CV Outcomes

Executive Summary

FDA’s decision to require a post-approval clinical trial evaluating the cardiovascular effects of Theratechnologies’ HIV lipodystrophy drug Egrifta shows the agency has overcome concerns – both its own and those of its advisory committee – that such a study could not be feasibly and ethically conducted.

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Egrifta Approval Suggests Evolution In FDA Thinking On Role Of REMS

FDA’s decision not to require a Risk Evaluation and Mitigation Strategy for Theratechnologies’ HIV lipodystrophy drug Egrifta (tesamorelin) suggests the agency is becoming more circumspect in how it applies its drug safety powers under the FDA Amendments Act more than two-and-a-half years after they took effect.

Egrifta Approval Suggests Evolution In FDA Thinking On Role Of REMS

FDA’s decision not to require a Risk Evaluation and Mitigation Strategy for Theratechnologies’ HIV lipodystrophy drug Egrifta (tesamorelin) suggests the agency is becoming more circumspect in how it applies its drug safety powers under the FDA Amendments Act more than two-and-a-half years after they took effect.

Delayed Egrifta Approval Brings Clean Label, No REMS For Theratechnologies

Tesamorelin becomes the first drug approved by FDA to treat HIV-related lipodystrophy.

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