From the Research
An AB rated drug is a generic medication that has been determined by the FDA to be therapeutically equivalent to its brand-name counterpart, containing the same active ingredient, strength, dosage form, and route of administration, and is expected to have the same clinical effect and safety profile when used according to the labeled conditions. This determination is based on the generic drug demonstrating bioequivalence to the brand-name drug, meaning the active ingredient is absorbed into the bloodstream at the same rate and to the same extent, typically shown through studies where the generic must deliver 80-125% of the active ingredient compared to the brand-name product 1. The AB rating system is important for pharmacists when substituting generics for brand-name prescriptions, as it provides assurance that the substitution will not affect the patient's treatment, and helps make medications more affordable while maintaining therapeutic effectiveness, as generics typically cost 80-85% less than their brand-name equivalents. Some key points to consider when evaluating AB rated drugs include:
- The FDA's determination of therapeutic equivalence is based on rigorous testing and evaluation of the generic drug's bioequivalence to the brand-name drug 2
- AB rated drugs are expected to have the same clinical effect and safety profile as their brand-name counterparts when used according to the labeled conditions
- The use of AB rated drugs can help reduce healthcare costs while maintaining therapeutic effectiveness, which is particularly important for patients with chronic conditions who require long-term treatment. It's worth noting that while the provided evidence does not directly address the question of what an AB rated drug means, the information from 1 and 2 provides context and support for the importance of the AB rating system in ensuring the therapeutic equivalence and safety of generic medications.