Primary-source regulatory summary. The efficacy values below are taken from the FDA Freedom of Information Summary for NADA 141-067. Use the linked FDA documents for the authoritative record and 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 FDA record describes treatment of anaemia in dogs by increasing systemic oxygen content and improving clinical signs associated with anaemia, regardless of cause.
| Key point | Detail |
|---|---|
| Condition | Anaemia in dogs |
| Functional target | Increasing systemic oxygen content / plasma hemoglobin concentration |
| Clinical effect | Improvement of clinical signs associated with anaemia |
| Causes | Hemolysis, blood loss, or ineffective erythropoiesis |
Dosage & Administration
| Parameter | Detail |
|---|---|
| Original Dose (1998) | 30 mL/kg once |
| Supplemental Approval | 10–30 mL/kg once |
| Infusion Rate | Up to 10 mL/kg/hour |
| Route | Intravenous |
| Cross-matching | Not required |
| Blood Transfusion | FDA field-trial safety analysis did not show evidence of adverse-reaction interaction with previous and/or post-treatment blood transfusions |
Key Regulatory Evidence
FDA endpoint: treatment success = no additional oxygen-carrying support required for 24 hours. This is an efficacy endpoint, not a survival endpoint.
| Endpoint / parameter | Result |
|---|---|
| Pivotal field trial | 64 client-owned anaemic dogs; 30 randomized to Oxyglobin and 34 to untreated control |
| Time to failure | Dogs treated with Oxyglobin had a longer time to failure than controls |
24-hour plasma hemoglobin time course — intent-to-treat population
| Time post-infusion | Mean change from pretreatment | SE | n |
|---|---|---|---|
| Immediate | +4.16 g/dL | 0.11 | 30 |
| 4 h | +3.77 g/dL | 0.13 | 29 |
| 12 h | +3.40 g/dL | 0.17 | 28 |
| 24 h | +2.84 g/dL | 0.18 | 23 |
All listed plasma-hemoglobin changes were statistically significant at p<0.001 using the Wilcoxon signed-rank test.
Physical Condition Scale time course — intent-to-treat population
| Time post-infusion | Mean PCS change | SE | n |
|---|---|---|---|
| Immediate | +1.21 | 0.13 | 28 |
| 4 h | +1.30 | 0.13 | 27 |
| 12 h | +1.17 | 0.16 | 26 |
| 24 h | +1.11 | 0.18 | 22 |
All listed PCS changes were statistically significant at p<0.001.
What does “Physical Condition Score +1.11” mean?
The FDA Physical Condition Scale quantified clinical signs associated with anaemia across three components: attitude, activity / exercise tolerance and resting heart rate. Activity ranged from recumbent and unable to stand at the low end to able to walk without tiring at the high end.
Therefore, the mean +1.11-point change at 24 hours represents measurable improvement from pretreatment in clinical signs associated with anaemia. FDA specifically describes improvement in lethargy/depression, exercise intolerance and increased heart rate for at least 24 hours.
PCS is not a survival score and must not be presented as one.
Safety Information
| Parameter | Detail |
|---|---|
| Volume-related risk | Infusion rate was reduced to 10 mL/kg/hr to improve safe use by preventing volume overload |
| Common findings at recommended dose | Discoloration of tissues/fluids, decreased appetite and thirst, vomiting, diarrhea and decreased skin elasticity are among findings described in the FDA safety record |
| Renal / tissue findings in target-animal safety study | The FDA record also describes renal hemosiderin deposition, tubular protein droplets/casts, reversible renal tubular damage and slight glomerulonephropathy in the laboratory safety study |
| Monitoring | Clinical monitoring is required; use the current official product information for prescribing decisions |
Sources
Primary FDA documents for NADA 141-067 and its dosage supplement. Cause-stratified treatment-success rates remain on the EMA / EU detail page.
Updated: 16 September 2026