In the pharmaceutical industry, NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) are both regulatory submissions to the U.S. Food and Drug Administration (FDA) for the approval of pharmaceutical products, but they differ in significant ways:
NDA (New Drug Application):
NDA is submitted by a pharmaceutical company seeking approval to market a new drug that has not been previously approved by the FDA.
It includes comprehensive data on the drug’s safety and efficacy obtained from preclinical and clinical trials, as well as information on the drug’s manufacturing process, labeling, and proposed indications for use.
The data submitted in an NDA must demonstrate that the drug is safe and effective for its intended use, and the FDA conducts a rigorous review process to evaluate the data before granting approval.
ANDA (Abbreviated New Drug Application):
ANDA is submitted for the approval of generic versions of already-approved drugs that have expired patents or exclusivity periods.
Unlike NDA, an ANDA does not require the submission of preclinical and clinical trial data to establish safety and efficacy. Instead, it relies on demonstrating bioequivalence to the reference listed drug (RLD), which is typically an innovator drug already approved by the FDA.
The applicant must demonstrate that the generic drug has the same active ingredient(s), dosage form, strength, route of administration, labeling, and manufacturing process as the RLD.
The review process for ANDA focuses on ensuring that the generic drug is therapeutically equivalent to the RLD, meaning it delivers the same amount of active ingredient(s) into the bloodstream within the same timeframe as the RLD.
In summary, NDA is for new drugs seeking FDA approval for the first time, while ANDA is for generic versions of already-approved drugs. NDA requires comprehensive data on safety and efficacy, whereas ANDA focuses on demonstrating bioequivalence to the reference listed drug.