Definition
sNDA (Supplemental New Drug Application) is an FDA submission requesting approval for changes to an already-approved drug product. Supplements cover new indications, formulations, manufacturing modifications, and labeling updates that cannot be implemented without FDA review.
How sNDA Works
After initial NDA approval, any significant change requires supplemental review. The scope of data required depends on the nature of the change and its potential impact on safety and efficacy.
Key Requirements
- Description of proposed change
- Supporting data (clinical, CMC, or stability as applicable)
- Updated labeling reflecting the change
- Comparison to currently approved product
- Risk assessment for the modification
Types of sNDA
| Type | Description | Review Timeline |
|---|---|---|
| Efficacy Supplement | New indication or population | 10 months (6 Priority) |
| Manufacturing Supplement | Site or process changes | 4-6 months |
| Labeling Supplement | Safety updates, warnings | 2-4 months |
| Prior Approval Supplement | Significant CMC changes | 4 months |
| CBE-30 | Changes Being Effected in 30 days | 30 days |
| CBE-0 | Immediate implementation | Immediate |
Why BD Teams Track sNDA
For business development professionals, sNDA activity signals lifecycle management:
- Deal Implication: Label expansions through sNDAs can significantly increase product value and trigger milestone payments
- Due Diligence Focus: Track competitor sNDAs for indication expansion into your therapeutic areas
- Opportunity Signal: Active sNDA programs indicate commitment to maximizing approved product value