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NDA approval letter: Zepbound (tirzepatide) injection [PDF]

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1 Measures of physical function improved as well, and in a post-hoc analysis, with more than one in eight patients treated with retatrutide reporting a complete freedom from knee pain at week 68, compared with 4.2% on placebo

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It means the benefit-risk profile must be proven through adequate trials, regulatory review, and continued safety monitoring