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1 In an effort to minimize unnecessary disruptions to patient treatment, the FDA confirmed that it does not intend to take enforcement action against outsourcing facilities and compounders for violations of the Federal Food, Drug, and Cosmetic Act (FDCA) arising from conditions that depend on tirzepatide injection products inclusion on the FDAs drug shortage list, or for compounding, distributing, or dispensing tirzepatide injection products that are essentially a copy of Mounjaro and Zepbound, during the following periods: However, the FDA may still take action against these parties regarding violations of other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe for patients
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A normal cycle lasts 3-4 months thats 2-3 months on, followed by one month off
[17] [16] Importantly, patients without baseline retinopathy did not demonstrate increased risk, and the overall cardiovascular benefits of semaglutide were maintained despite this ocular safety signal
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