What’s are ANDA and NDA? What are the Difference between NDA and ANDA?
NDA (New Drug Application):
A New Drug Application (NDA) is submitted by the sponsor of a new drug when they believe they have gathered sufficient evidence to demonstrate the drug’s safety, efficacy, and compliance with the FDA’s quality standards. This application is required for new drugs that have not been previously approved by the FDA.
The NDA includes comprehensive data from preclinical (animal) and clinical (human) studies to prove that the drug is safe and effective for its intended use. If the FDA approves the NDA, the drug can be marketed and sold in the United States.
Difference Between NDA and ANDA
ANDA (Abbreviated New Drug Application):
An Abbreviated New Drug Application (ANDA) is submitted for the approval of a generic drug, which is a copy of an already FDA-approved brand-name drug. Unlike an NDA, an ANDA does not require extensive preclinical and clinical data to establish safety and efficacy. Instead, the applicant must demonstrate that the generic drug is bioequivalent to the reference listed drug (RLD), meaning it performs in the same manner as the original drug. This streamlined process allows generic drugs to be approved and marketed as safe, effective, and affordable alternatives to the brand-name versions.
Key Differences:
- Purpose:
- NDA: For new drugs that have not been previously approved.
- ANDA: For generic versions of already approved drugs.
- Data Requirements:
- NDA: Requires extensive preclinical and clinical data to prove safety and efficacy.
- ANDA: Requires bioequivalence data to show similarity to the reference drug.
- Approval Process:
- NDA: Involves a thorough review of new drug data.
- ANDA: Focuses on demonstrating equivalence to an existing approved drug.
- Cost and Time:
- NDA: More expensive and time-consuming due to the need for original research.
- ANDA: Less costly and faster, as it relies on existing data from the reference drug.
Once the FDA determines that a drug (whether through an NDA or ANDA) is safe, effective, and meets manufacturing and labeling standards, an approval letter is issued. This letter authorizes the marketing and sale of the drug in the United States, with the approval effective from the date of issuance.
In summary, NDAs are for new drugs requiring full safety and efficacy data, while ANDAs are for generic drugs that rely on bioequivalence data to reference an already approved drug. Both pathways ensure that drugs meet FDA standards for public use.
About CB-0, CB-30 and PAS in ANDA submission
When a pharmaceutical company receives FDA approval for an Abbreviated New Drug Application (ANDA) to produce a generic medication, the approved ANDA outlines specific details such as manufacturing processes, product composition, labeling, and other critical aspects. However, if the company wishes to make changes to the product post-approval, the type of submission required depends on the nature and potential impact of the change. Here’s how CBE-0, CBE-30, and PAS submissions apply:
CBE-0 (Changes Being Effected – Level 0):
If the company decides to make a minor change, such as altering the color of the tablets to enhance patient identification, and this change does not affect the drug’s safety, efficacy, or quality, a CBE-0 notification can be submitted to the FDA. The company can implement the change immediately after submitting the notification without waiting for FDA approval.
CBE-30 (Changes Being Effected – Level 30):
For a more substantial change, such as updating the design of the drug’s outer carton packaging, which still does not impact the drug’s safety, efficacy, or quality, the company must submit a CBE-30 notification. This requires informing the FDA at least 30 days before distributing the product with the new packaging. If the FDA does not raise objections within the 30-day period, the company can proceed with the updated packaging.
PAS (Prior Approval Supplement):
In cases where the company proposes a significant change, such as modifying the drug’s formulation by substituting an inactive ingredient that could affect the dissolution profile and potentially alter the drug’s bioavailability or therapeutic efficacy, a Prior Approval Supplement (PAS) is required. This type of submission necessitates FDA review and approval before the company can implement the new formulation.
In summary, CBE-0 and CBE-30 submissions are used for minor changes with minimal impact on the drug product, while a PAS submission is necessary for major changes that could influence the drug’s safety, efficacy, or quality. Each submission type ensures that the FDA is appropriately informed and can assess the potential impact of the proposed changes.


Keywords in Pharmasciences:
- ANDA submissions
- CBE-0
- CBE-3
- PAS submission
- FDA post-approval changes
- Abbreviated New Drug Application
- FDA regulatory compliance
- Pharmaceutical manufacturing changes
- Generic drug approval process
- FDA submission types
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