For delayed methotrexate clearance (plasma methotrexate concentrations greater than 2…. BLA 125327, held by Btg International Inc. Glucarpidase.
As of Nov 13, 2026, BLA 125327 (Voraxaze), held by Btg International Inc, was first approved by FDA on Jan 17, 2012, with 2 approved supplements and 0 published complete response letters.
VORAXAZE is indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function. Limitations of Use: VORAXAZE is not recommended for use in patients who exhibit the expected clearance and expected plasma methotrexate concentration. Reducing plasma methotrexate concentration in these patients may result in subtherapeutic exposure to methotrexate.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 17, 2012 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Voraxaze1000 UNITS PER VIAL · injectable; injection | Glucarpidase | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 13, 2019 | Supplement 64Labeling · Standard review | Approved | |
| Mar 29, 2013 | Supplement 20Labeling · Standard review | Approved | |
| Jan 17, 2012 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
