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According to Rosen, its a pretty straightforward determination by the FDA that a shortage has been resolved: Do they have sufficient materials in the supply chain, and can they meet the market demand for the product? In my experience, FDA wants at least one year of finished goods in stock, and six months or more of raw materials to be able to continue to make sure that the pipeline is secure, Rosen said

Ideal candidates are those who have struggled with traditional cholesterol medications due to side effects (like muscle pain from statins) or who have not achieved target cholesterol levels through diet and exercise alone

Combined with the increased preload, this can lead to heart failure in susceptible individuals

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