NDAORALTABLETPriority Review
Approved
Oct 1956
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
HALOTESTIN (fluoxymesterone) by Pfizer is clinical pharmacology endogenous androgens are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. First approved in 1956.
Drug data last refreshed 16h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HALOTESTIN (fluoxymesterone) is an oral synthetic androgen approved in 1956 that mimics endogenous testosterone to treat androgen deficiency and certain anemias. It works by binding androgen receptors to promote protein anabolism, nitrogen retention, and red blood cell production. The drug is indicated for testosterone replacement therapy and select hematologic conditions in both adult and pediatric populations.
LOE Approaching
As LOE approaches, Pfizer's brand team is likely focused on lifecycle optimization and defending against generic erosion; team size is expected to remain modest given the mature, niche indication profile.
Mechanism of Action
CLINICAL PHARMACOLOGY Endogenous androgens are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair…
Indications
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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.