FdaApplication
NDA 216660
Identifiers
- fda_app_no: NDA216660
Properties
| Property | Value |
|---|---|
| applicant_name | AMYLYX PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2022-09-29 |
Revenue by product
RELYVRIO
| Period | Revenue |
|---|---|
| Q4 2025 | $0.0M*† |
| Q3 2025 | $0.0M*† |
| Q2 2025 | $0.0M*† |
| Q1 2025 | $0.0M*† |
| Q4 2024 | $-0.7M*† |
| Q3 2024 | $0.4M*† |
| Q2 2024 | $-1.0M*† |
| Q1 2024 | $88.6M*† |
| Q4 2023 | $108.4M*† |
| Q3 2023 | $102.7M*† |
| Q2 2023 | $98.2M*† |
| Q1 2023 | $71.4M*† |
| Q4 2022 | $21.9M*† |
| Q3 2022 | $0.3M*† |
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. A fourth quarter is the reported full year less nine months, since no filing states one. A figure marked † is the company's one reported revenue line rather than a product breakdown.
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| RELYVRIO | SODIUM PHENYLBUTYRATE; TAURURSODIOL | 3GM/PACKET;1GM/PACKET | FOR SUSPENSION;ORAL |
1 product