NDAINTRAVENOUSPOWDER
Approved
Sep 2016
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
4/8 — Partial
LEVOLEUCOVORIN CALCIUM (levoleucovorin calcium) by Teva is high-dose methotrexate therapy levoleucovorin is the pharmacologically active isomer of 5-formyl tetrahydrofolic acid. Approved for pernicious anemia, megaloblastic anemia secondary to lack of vitamin b 12, because of the risk of progression of neurologic manifestations despite hematologic remission. First approved in 2016.
Drug data last refreshed 17h ago · AI intelligence enriched 22h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Levoleucovorin calcium is the pharmacologically active isomer of 5-formyl tetrahydrofolic acid, used as a rescue agent after high-dose methotrexate therapy and as an adjunct to fluorouracil in colorectal cancer treatment. It counteracts the toxic effects of folic acid antagonists and enhances fluorouracil efficacy by stabilizing thymidylate synthase inhibition. The drug is administered intravenously as a powder formulation.
$0.013BPart D
PeakProduct is in peak commercial maturity with modest Part D utilization; stable, established franchise with limited team expansion.
Mechanism of Action
High-Dose Methotrexate Therapy Levoleucovorin is the pharmacologically active isomer of 5-formyl tetrahydrofolic acid. Levoleucovorin does not require reduction by the enzyme dihydrofolate reductase in order to participate in reactions utilizing folates as a source of “one-carbon” moieties.…
Indications (3)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.