FDA Policy/General

OPDP Faults Roszet Promotion

The CDER Office of Prescription Drug Promotion (OPDP) says an Althera Pharmaceuticals professional communications piece for Roszet (rosuvastatin and ezetimibe) tablets makes false or misleading claims and representations about the risks and efficacy of Roszet. A 6/2 Untitled Letter says the violations are concerning from a public health perspective “because the promotional communication creates a misleading impression regarding the safety and effectiveness of Roszet, which is a drug with multiple serious and potentially life-threatening risks.”

OPDP says the Roszet labeling says the drug is indicated in adults as an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C), and alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia to reduce LDL-C.

The seven-page letter discusses Contraindications, Warnings, Precautions, and Adverse Reactions shown in the labeling. It says the promotional material claims that attribute specific levels of LDL-C reductions to the product at various dosages are misleading because they are not the findings of any Roszet study.

Likewise, it says, the promotion has claims and presentations that create a misleading impression about Roszet’s efficacy in achieving specific levels of LDL-C reduction over specific time periods. OPDP says there are multiple limitations to the cited studies that preclude drawing conclusions regarding the quantitative treatment effect of Roszet on LDL-C based on the studies.

OPDP further says the communication is misleading because it fails to present information relating to the Contraindications and Warnings and Precautions for Roszet with a prominence and readability reasonably comparable with the presentation of benefits information.

Althera was told to respond to the concerns listed in the Untitled Letter, listing all promotional communications for Roszet that contain representations like those described in the letter and a plan for discontinuing the use of such communications or for ceasing distribution of Roszet.

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