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What is supplemental new drug application (sNDA)
27 Sep 2023

What is supplemental new drug application (sNDA)?

From a regulatory perspective, supplemental new drug application is filed to to make changes in a product that already has an approved new drug application.

Application submitted for an already approved NDA (New Drug Application) for any changes in packaging, labelling, dosages, ingredients or new indications is termed as supplemental new drug application. In short, it is called as sNDA. 

CDER must approve all important NDA changes (in packaging or ingredients, for instance) to ensure the conditions originally set for the product are still met.

If the FDA approves the sNDA, the changes specified in the application are incorporated into the drug's labeling and prescribing information. The drug can then be marketed and prescribed according to the newly approved changes.

 

Royed International Drug Regulatory Affairs

A supplement number is associated with an existing FDA New Drug Application (NDA) number. Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001.

Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). The supplement type refers to the kind of change that was approved by FDA. This includes changes in manufacturing, patient population, and formulation.

Importance of supplemental new drug application (sNDA)

The supplemental new drug application (sNDA) process allows pharmaceutical companies to keep their drugs up-to-date with new scientific findings, expand their utility, and make necessary changes in response to evolving medical knowledge and patient needs. Hence, it plays a crucial role in ensuring that approved drugs continue to meet high standards of safety and effectiveness throughout their lifecycle.

Changes accepted under supplemental new drug application (sNDA)

sNDAs are typically submitted when a pharmaceutical company wants to make changes to an approved drug, such as:

  • Expanding the approved indications (new uses) of the drug.
  • Modifying the recommended dosage or administration regimen.
  • Adding new safety or efficacy data that were not included in the original NDA.
  • Updating the drug’s labeling, packaging, or manufacturing specifications.
When seeking approval for new indications or significant changes, sNDAs often include additional clinical data, such as results from clinical trials, to support the proposed changes.

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