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FDA's evaluation concluded that the criteria weighed against placement on the list, citing inadequate physicochemical characterization, immunogenicity concerns from impurities and aggregates, lack of clinical effectiveness data for any approved use, and absence of published human exposure data for the proposed subcutaneous and topical routes
[1] There is no official clinical guidance regarding the concurrent use of lipotropic injections with tirzepatide, as Lipo C formulations are unapproved compounded products that have not been reviewed by the FDA
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