New drug Application (NDA) Vs Abbreviated New drug Application (ANDA)

What is New drug Application (NDA) :

  1. A new drug application (NDA) is a complete document that must be submitted to the U.S. Food and Drug Administration (FDA) in order to request approval for marketing a new drug in the United States.

2. Drugs for which NDAs are submitted required four phases of clinical trials and drugs that reach the NDA phase typically have a high probability of getting FDA approval.

3. NDA document must contain detailed experimental evidence (including both animal and human studies) and the document required the proposed drug’s pharmacology, toxicology, and dosage requirements as well as the intended process for manufacturing the drug. 

4. A lot of money is required for New drug Application (NDA)

5. Cost or price of drug is more in comparison to ANDA

6. Long time is required for NDA Approval.

What is Abbreviated New drug Application (ANDA) :

  1. An abbreviated new drug application (ANDA) contains data which is submitted to Food and Drug Administration (FDA)  for the review and of a generic drug product.

2. After approval the organization or company can manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug.

3. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.

4. For generic drugs bioequivalence” (which gives the rate of absorption) and bioavailability is required which can be compared to that of the innovator drug.

5. Less money is required for Abbreviated New drug Application (ANDA) in comparison to NDA.

6. Cost or price of drug is less in comparison to NDA

7. Less time is required for getting approval


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