FdaApplication
NDA 219666
Identifiers
- fda_app_no: NDA219666
Properties
| Property | Value |
|---|---|
| applicant_name | PTC THERAPEUTICS INC |
| application_type | NDA |
| approval_date | 2025-07-28 |
Revenue by product
SEPHIENCE
| Period | Revenue |
|---|---|
| Q2 2026 | $151.3M |
| Q1 2026 | $124.6M |
| Q3 2025 | $19.6M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients.
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SEPHIENCE | SEPIAPTERIN | 1GM/PACKET | POWDER;ORAL |
| SEPHIENCE | SEPIAPTERIN | 250MG/PACKET | POWDER;ORAL |
2 products