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Generic Vs Branded - Effectiveness Ensurance BY FDA

Are generic medicines as effective and safe as brand-name ones and how does the FDA ensure their safety and effectiveness?

 

These follow are :-

 

  • Generic medicines adhere to the same standards as brand-name counterparts, encompassing dosage, form, route of administration, safety, effectiveness, strength, and labeling.

 

  • They contain identical active ingredients, operating in a parallel manner, with equivalent risks and benefits as brand-name medications.

 

  • The FDA Generic Drugs Program rigorously ensures compliance with these standards, employing thorough reviews, manufacturing plant inspections, and post-approval safety monitoring.

 

  • Minor differences in inactive ingredients may exist, but they fall within FDA-established acceptable limits.

 

  • A study comparing generics to brand-name drugs revealed minimal differences (around 3.5%) in absorption into the body, deemed clinically acceptable.

 

  • Generic medicines deliver comparable performance to brand-name counterparts, accompanied by cost savings.

 

Source:-https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers#:~:text=about generic medicines%3F-,What are generic drugs%3F,performance characteristics%2C and intended use. 

 

Disclaimer:-This information is not a substitute for medical advice. Consult your healthcare provider before making any changes to your treatment. Do not ignore or delay professional medical advice based on anything you have seen or read on Medwiki. 

 

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Disclaimer:

This information is not a substitute for medical advice. Consult your healthcare provider before making any changes to your treatment. Do not ignore or delay professional medical advice based on anything you have seen or read on Medwiki.

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Dr. Beauty Gupta

Published At: Feb 15, 2024

Updated At: Nov 15, 2024