12/10/2024
Harold Robert Meyer and The ADD Resource Center
No, the FDA requirements for generic and brand-name drugs differ in several important ways, although both must adhere to strict safety standards.
Key differences include:
For brand-name drugs (New Drug Applications/NDAs):
- Must conduct extensive clinical trials to prove both safety and efficacy
- Must provide complete data about drug discovery, chemistry, manufacturing, controls, and testing
- Must submit studies showing how the drug works in the body
- Required to demonstrate therapeutic benefit
For generic drugs (Abbreviated New Drug Applications/ANDAs):
- Do not need to repeat clinical trials
- Must prove “bioequivalence” to the brand-name drug, meaning:
- Same active ingredient
- Same strength
- Same dosage form
- Same route of administration
- Absorbed into the bloodstream at similar rate and extent
- Must show acceptable manufacturing standards and controls
- Can often rely on the brand-name drug’s safety and efficacy data
- Can only be approved after brand-name patent and exclusivity periods expire
The generic must deliver the same amount of active ingredient to the body within an acceptable range (typically 80-125% of the brand-name drug’s bioavailability). However, inactive ingredients (colors, fillers, etc.) can differ, which occasionally affects how individual patients respond to generics versus brand-name drugs.
© 2024 The ADD Resource Center. All rights reserved. 12/10/2024
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