NDAINJECTIONINJECTABLE
Approved
Jun 1947
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
17
Data completeness
3/8 — Basic
FOLVITE (folic acid) by Pfizer is clinical pharmacology folic acid acts on megaloblastic bone marrow to produce a normoblastic marrow. First approved in 1947.
Drug data last refreshed 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOLVITE (folic acid) is a water-soluble B vitamin indicated for treatment of megaloblastic and macrocytic anemias caused by folic acid deficiency. It works by converting to tetrahydrofolic acid, a cofactor essential for nucleoprotein synthesis, DNA synthesis, and normal red blood cell formation. The injectable formulation enables rapid absorption and systemic distribution for patients unable to tolerate or absorb oral folate.
LOE Approaching
As an approaching LOE product with moderate competitive pressure (30%), brand teams face declining revenue trajectory and likely resource consolidation.
Mechanism of Action
CLINICAL PHARMACOLOGY Folic acid acts on megaloblastic bone marrow to produce a normoblastic marrow. In man, an exogenous source of folate is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as…
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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.