Authorized generics are brand-name drugs sold without the brand name, made by the same company with identical ingredients. They offer a middle-ground option between expensive brands and cheaper traditional generics, with no formulation changes.
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The FDA allows bioequivalence waivers for certain generic drugs when in vitro dissolution data proves they perform like brand-name versions. This saves time and money while ensuring safety - but only for drugs meeting strict BCS Class I or III criteria.
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