Understand the Abbreviated New Drug Application in Pharmaceutical

Background: 

    Today here we are going to discuss Abbreviated New Drug Application (ANDA) in pharmaceutical and how ANDA has arrived in the industry.
 
      In the early days of 1970, the applicant was filing the NDA for the manufacturing of the new drug, it was taking more time to invent new drugs and the study of the new drugs was more expensive and has to pass through so many tests.
 
    If a drug study found satisfactory then the applicant gets approval from the Food and Drug Administration (FDA) but fails then a huge loss in terms of time, expense, resources and so many for the drug-making applicants. Hence to overcome this situation the FDA introduced an ANDA mechanism in the 1970s.

 

      Now a days most of the Pharma companies are focus on ANDA filings. In 1970,the Food and drug administration (FDA) has established a ANDA mechanism for review and approval of the generic version of drug.
 
     From 1970 to 1978 the applicants of generic drug product required to submit complete safety and efficacy data through clinical trial.
   
       In 1978, the applicants were required to submit the published article of clinical trial also for safety and efficacy. 
        

Definition of Abbreviated New Drug Application (ANDA) as per FDA:

   ” Abbreviated New Drug Application is a request or application that contains the review and potential approval of submitted data by Food and Drug administration’s (FDA’S) office of Center for Drug Evaluation and Research, for manufacture and market a generic drug product in the US.” 

 

Goal of ANDA:

         ” The ultimate goal of Abbreviated New Drug Application (ANDA) is to provide high quality, safe, and affordable medicine to the patient.”

 

Mandatory requirements for ANDA:

      For the approval of ANDA for generic drug product by the Food and drug administration some basic requirements are to be followed by the applicants are:
  1. The generic drug product should contain the same active ingredient as available in the innovator drug product but inactive ingredients (also known as excipient) may vary.
  2. The generic drug product should contain identical or more safety and efficacy than the innovator drug product.
  3. The generic drug product should contain identical strength, dosage form and route of administration as an innovator drug product.
  4. The generic drug product must be bioequivalent to the innovator drug product.
  5. The generic drug product should have the same use or indication.
  6. The generic drug must have same Batch requirements for safety, identity and purity.
  7. The generic drug applicant strictly follows the food and drug administration cGMP standard’s commonly known as Hatch- Waxman act.

General information of Abbreviated New Drug Application:

     The generic drug product is relatively cheaper and takes lesser time to get approval from the FDA than the innovator drug product.
 
      The generic drug application is termed as “Abbreviated” because (in comparison with New Drug Application) they are not required to include preclinical (animal) and clinical (human) trial data to define the safety and effectiveness of the drug product. 
   
    Here the CDER reviewer focus on bioavailability, bioequivalence data, chemistry and microbiology data. Request for plant inspection and drug labeling information. The applicant must scientifically prove that their generic drug product is working in the same manner as an innovator drug product.
   
    The applicant here assures that their generic drug product is equivalent to the innovator drug product by providing the bioequivalence or bioavailability study data. The generic drug has to deliver the same active drug into the patient’s body and in the same amount of time as an innovator drug product.
 
    In 1984, FDA introduced a ” Drug price competition and patent term restoration act” of 1984, commonly known as”Hatch-Waxman act 1984″.
 
     The Hatch-Waxman act is dealing with the approval of generic drug products and associated conditions for getting approval from the FDA, market exclusivity, rights of exclusivity, patent term extension and orange book listing. 
 
What is the general provision of the Hatch-Waxman act:
 
  • Maintaining a listed patent which would be infringed.
  • The data exclusivity period for a new molecular entity
  • Paragraph I, II, III and IV certification.
  • Only bioavailability study data and not clinical trial data needed for approval.
  • Extension of the original patent term.

Newly added provision for the act:    

Some new provision was added under the act of “Medicare prescription drug and modernization act” 2003.

  • Timeline is set for informing the owner of the patent drugs.
  • Nonextension of 30 month period.
  • The benefit of exclusivity for several ANDA’s files on the same day allowed.
  • Provision for allowing declaratory judgment.
     
After getting ANDA approval from the FDA, the applicant is ready to manufacture a generic drug and free to sell their generic drug product into the US market.

 

     All generic drug and innovator drugs are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

 

References:

 
  • The Federal Food, Drug, and Cosmetic act.
  • Code of Federal Regulation:

 

b.   21CFR Part 320: Bioavailability and Bioequivalence Requirements

 

Abbreviated New Drug Application
Abbreviated New Drug Application (ANDA)
 

 

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