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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

doi:10.1016/j.jacc.2024.08.021 Ouimet M, Hennessy EJ, van Solingen C, et al

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Allergic reactionsincluding rash, swelling, or difficulty breathingare rare but require immediate medical attention and discontinuation of the medication

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