Abbreviated New Drug Application (ANDA)

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Abbreviated New Drug Application (ANDA)


An abbreviated new drug application (ANDA) contains information that is submitted to the FDA for examination and possible approval of a generic drug product. Once approved, an application may produce and promote the generic drug product as a safe, effective, and less expensive alternative to the brand-name drug it references.

Generic drug applications are referred to as "abbreviated" since they are typically not required to include preclinical (animal) and clinical (human) evidence to show safety and effectiveness.


Key points about ANDAs:


  1. Bioequivalence: Generic medicinal products approved through ANDA must be bioequivalent, which means they are absorbed into the bloodstream at the same rate and extent as the brand-name drug.
  2. Cost Savings: Generic drugs approved through the ANDA process are often less expensive than their brand-name counterparts, increasing affordability and access to important medications.
  3. Exclusivity Period: Generic manufacturers may submit an ANDA after the brand-name drug's exclusivity period has expired, allowing for competition and perhaps driving down prices.
  4. Regulatory requirements: While ANDAs have a more streamlined approval procedure than NDAs, they must nonetheless adhere to stringent regulatory requirements for safety, quality, and efficacy.
Basic Generic Drug Requirements are:

same active ingredients
same route of administration
same dosage form
same strength
same conditions of use
inactive ingredients already approved in similar NDA 


Goal of ANDA   

To reduce the price of the drug.
To reduce the time development,
increase the bioavailability of the drug in comparison to references list drugs,

ANDA certification Clauses
PARA I: Required patent information has not been filed.
PARA II: Patent has expired
PARA III: The FDA may approve generics immediately, and one or more applications may enter.
PARA IV: The FDA may approve generics, and one or more applicants may enter

ANDA review process:





The CTD is organized into five modules: 

Module 1. Administrative Information and Prescribing Information 
Module 2. Common Technical Document Summaries 
Module 3. Quality 
Module 4. Nonclinical Study Reports 
Module 5. Clinical Study Reports




 











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