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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

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It consists of a quinoline ring, which is a bicyclic aromatic system of a benzene and pyridine ring

That's the rule, and it doesn't change based on payer

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