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Formal inclusion means the FDA has determined, after applying its statutory and regulatory process, that a specified bulk drug substance can be used under the section 503A bulks-list pathway when all other conditions are met
Following the success and approval of tirzepatide (Mounjaro, Eli Lilly, Indianapolis, IN, USA) in 2022 by FDA for treatment of T2DM, the SURMOUNT programme investigated its use as an anti-obesity medication in those without diabetes
The mechanism involves actin binding
These providers may prescribe medications for metabolic health when clinically appropriate
However its only available on Aulines website at the moment
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