Application 761090
- Type
- BLA
- Sponsor
- DYAX CORP.
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761090 | Takhzyro | lanadelumab-flyo | 351(a) | Disc | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TAKHZYRO | LANADELUMAB (SHP643) | INJECTABLE;INJECTION | 300MG/ML(150MG/ML) | No | No |
| 002 | TAKHZYRO | LANDELUMAB-FLYO | SOLUTION;SUBCUTANEOUS | 300MG/2ML (150MG/ML) | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 7 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 47783-644 | TAKHZYRO | lanadelumab-flyo | Dyax Corp. | BLA | Current |
| 47783-644 | TAKHZYRO | lanadelumab-flyo | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 47783-644 | TAKHZYRO | lanadelumab-flyo | Dyax Corp. | BLA | Current |
| 47783-644 | TAKHZYRO | lanadelumab-flyo | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 47783-644 | TAKHZYRO | lanadelumab-flyo | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 47783-646 | TAKHZYRO | lanadelumab-flyo | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 47783-646 | TAKHZYRO | lanadelumab-flyo | Takeda Pharmaceuticals America, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73395 | SUPPL | 2023-02-07 |
| 73388 | SUPPL | 2023-02-06 |
| 71191 | SUPPL | 2022-06-01 |
| 56520 | SUPPL | 2018-11-20 |
| 56506 | SUPPL | 2018-11-20 |
| 55532 | ORIG | 2018-09-20 |
| 55507 | ORIG | 2018-09-18 |
| 55283 | ORIG | 2018-08-24 |