Anavip Purple Book BLA 125488
- BLA number
- 125488
- Proprietary names
- Anavip
- Proper names
- Crotalidae Immune F(ab')2 (Equine)
- Applicant
- Rare Disease Therapeutics, Inc. (RDT)
- Center
- CBER
- First observed release
- 2020-08-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Anavip | Crotalidae Immune F(ab')2 (Equine) | 351(a) | MINIMUM 780 BOTHROPS ASPER, 790 C.SIMUS, 244 C.ADAMANTEUS, 147 C.ATROX, 185 C.SCUTULATUS, 28 AGKISTRODON CONTORTRIX, 61 A.PISCIVORUS LD50 NEUTRALIZING UNITS/VIAL | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2015-05-06 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2022-06-01 | U | 001 | Anavip | 351(a) | Rx | Rare Disease Therapeutics, Inc. (RDT) |
| 2021-09-01 | U | 001 | Anavip | 351(a) | Rx | Rare Disease Therapeutics, Inc. (RDT) |
| 2021-05-01 | U | 001 | Anavip | 351(a) | Rx | Rare Disease Therapeutics, Inc. (RDT) |
| 2020-08-01 | R | 001 | Anavip | 351(a) | Rx | Rare Disease Therapeutics, Inc. (RDT) |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-08-01 | 001 | Anavip | 351(a) | Rx | Licensed | 2015-05-06 |