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The FDA's delisting of tirzepatide injection products was neither procedurally defective nor arbitrary and capricious. The Fifth Circuit Court of Appeals affirmed summary judgment in favor of the FDA and Eli Lilly & Company in a challenge brought by compounding pharmacies and their trade association over the FDA's December 2024 decision to remove tirzepatide injection products from the federal drug shortage list. The court held that even assuming the FDA should have employed notice-and-comment…

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DRUGS AND BIOLOGICS—5th Cir.: Fifth Circuit upholds FDA's removal of tirzepatide from drug shortage list, rejecting compounders' APA challenges