Overview
In the pharmaceutical and related clinical environment, these two terms are central: New drug application also known as NDA and Supplemental New Drug Application regarded as sNDA. Both are involved in the approval and regulation of drugs, though they have different functions and are used at various stages of the drug’s existence. This blog post offers further discussion on sNDA, its meaning, main characteristics, and its distinctions from NDA as well as examples of the drugs that have gone through said processes.
Understanding sNDA
sNDA stands for Supplemental New Drug Application. It is an application that a company makes to the FDA to permit alteration of an already approved new drug application. These changes can encompass alterations to the side of the drug that one sees and understands, the labeling that is placed on the drug or the way it is made or even the discovery of other uses for the drug. The sNDA process also makes for the capability of any major changes in the drug to undergo the FDA approval in order to preserve the safety and effectiveness as stipulated.
Key Components of sNDA
Purpose of an sNDA:
• Labeling Changes: New information the FDA obtains that affects the drug’s labeling or information medical practitioners use when directing patients.
• New Indications: To secure its usefulness in the treatment of other diseases and or condition, it is requested that the mentioned drug be approved for further usage.
• Dosage or Formulation: Selecting a different type of drug, to be administered in a different manner, or a different strength or preparation of the same drug.
• Manufacturing Changes: Details concerning the process of making the drug; for instance, alteration of the production venue or the technological procedure.
Submission Process:
- Application: Normally, the changes are proposed by the sponsor which is usually a pharmaceutical firm and the sNDA together with supporting data is forwarded to the FDA.
- Review: The FDA reviews this submission to determine some of the effects that these changes may cause, relating to the safety and efficacy of the drug.
- Approval: If the changes receive FDA approval through the submission of sNDA, then it follows that labeling or indications of the drug will have to change.
- Formulation Changes: Some changes done on the composition of the drug.
Difference between NDA and sNDA
NDA (New Drug Application)
- The first submission made by any company to the FDA to approve a new drug is referred to as NDA. It presents all supporting information from the clinical trials of the drug, preclinical information to details of the manufacture of the drug to show its efficiency and safety.
- Scope: Involves the clinical information on a new drug, clinical trial information, labeling information, and manufacturing information in a drug.
- Process: Entails clinical trials as well as other procedure for a new drug before it can be launched to the market.
sNDA (Supplemental New Drug Application)
- sNDA (Supplemental New Drug Application) is submitted after the NDA. It is used in an attempt to seek amendment on any information that the initial drug application provided.
- Focus: It is a trail of an already approved drug in which the applicant seeks approval for a specific modification to the previous approved drug such as a new use or change in formulation.
- Process: It is usually characterized by a more detailed examination of the proposed changes according to the data that was initially included in the original NDA.
EXAMPLES
- NDA Example:
Drug: Lipitor (atorvastatin)
Purpose: Particularly given in the past to lower both cholesterol levels and the cases of heart disease among patients.
- sNDA Example:
Drug: Keytruda (pembrolizumab)
Purpose: Initially, it was approved only for the melanoma treatment.
sNDA Approval: Other sNDAs have been submitted and approved for other indication(s) including non-small cell lung cancer and head and neck cancer on the basis of clinical trial.
Conclusion
In conclusion, the sNDA process is important because any subsequent changes to an approved drug are subjected to validation to retain its safety and efficacy standards. Thereby, comprehending the variances between NDA and sNDA contributes to the ability to evaluate the functioning of the regulations that guarantee the supply of efficient and safe medications.