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"The manufacturer must show that these differences do not affect the safety, efficacy or quality of the drug compared to the brand name drug." Pricing depends on a few factors, said Mina Tadrous, an associate professor at the Leslie Dan Faculty of Pharmacy at the University of Toronto

Yes, the FDA-approved Tirzepatide for weight loss under the trade name Zepbound in November 2023

For example, Yu et al

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PubMed Rahaman, K.A., Muresan, A.R., Min, H., Son, J., Han, H., Kang, M., & Kwon, O

An FDA decision is anticipated by late 2026