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 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HALOTESTIN (fluoxymesterone) is an oral synthetic androgen approved in 1956 for testosterone replacement and treatment of delayed male puberty. It works by mimicking endogenous androgens to promote normal growth and development of male sex organs, secondary sex characteristics, and protein anabolism. The drug has a half-life of approximately 9.2 hours and acts through feedback inhibition of pituitary LH and FSH at higher doses.
LOE Approaching
As a near-LOE legacy oral androgen with moderate competitive pressure (30/100), career roles will focus on maximizing remaining exclusivity and managing transition to generics.
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.