Archival source note. Detailed numerical and clinical summaries below were retained from the supplied repository notes and have not all been independently revalidated. Use the linked official documents for authoritative wording and current labelling. Open the regulatory source library.
FDA Approval — Oxyglobin (NADA 141-067)
Overview
| Parameter | Detail |
|---|---|
| Approval Number | NADA 141-067 |
| Approval Date | 1998-01-12 |
| Sponsor | Biopure Corporation |
| Product Name | Oxyglobin |
| Established Name | hemoglobin glutamer-200 (bovine) |
| Dosage Form | Prescription injectable (IV) |
| Species | Dogs |
US Veterinary Approval
Oxyglobin was approved by the FDA under New Animal Drug Application NADA 141-067.
Official Records
- FDA Freedom of Information Summary for the original approval — NADA 141-067
- FDA supplemental approval record and revised dosage information
Indication
The original FDA approval states the indication as:
Treatment of anaemia in dogs by increasing systemic oxygen content and improving associated clinical signs for at least 24 hours, regardless of the cause of the anaemia.
| Key Point | Detail |
|---|---|
| Condition | Anaemia in dogs |
| Mechanism | Increasing systemic oxygen content |
| Duration | At least 24 hours |
| Causes | Regardless of cause (hemolysis, blood loss, ineffective erythropoiesis) |
Dosage & Administration
| Parameter | Detail |
|---|---|
| Original Dose (1998) | 30 mL/kg once |
| Supplemental Approval (2006) | 10–30 mL/kg once |
| Infusion Rate | Up to 10 mL/kg/hour |
| Route | Intravenous (central or peripheral) |
| Cross-matching | Not required |
| Blood Transfusion | Not contraindicated after Oxyglobin |
Key Regulatory Evidence
| Parameter | Result |
|---|---|
| Pivotal Field Trial | 64 client-owned anemic dogs |
| Success Rate (Efficacy Population) | 95% (20/21) vs 32% (9/28); p≤0.001 |
| Success Rate (ITT) | 73% (22/30) vs 29% (10/34); p≤0.001 |
| Time to Failure | Significantly longer for Oxyglobin (p<0.001) |
| Clinical Improvement | Plasma hemoglobin and physical-condition scores improved significantly (p<0.001) |
Safety Information
| Parameter | Detail |
|---|---|
| Primary Risk | Circulatory overload at rates >10 mL/kg/hr |
| Common Adverse Reactions | Discoloration, GI effects, cardiovascular and respiratory findings, fever, volume-related complications |
| Contraindications | Dogs at risk of circulatory overload (advanced cardiac disease, renal impairment with oliguria/anuria) |
| Monitoring | Signs of circulatory overload or CVP measurement |
Source
FDA documents (NADA 141-067, supplements)
Last updated: 2026.08