NDAORALCAPSULE
Approved
Oct 2006
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
7/8 — Comprehensive
TIROSINT (levothyroxine sodium) by Pfizer is synthesis. Approved for hypothyroidism, congenital hypothyroidism. First approved in 2006.
Drug data last refreshed 18h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIROSINT is an oral capsule formulation of levothyroxine sodium approved by the FDA in October 2006 as an NDA product by Pfizer. It is indicated for the treatment of primary, secondary, and tertiary hypothyroidism in both pediatric and adult populations, including transient hypothyroidism during recovery from subacute thyroiditis. The drug works by replacing or supplementing endogenous thyroid hormones; levothyroxine (T4) is converted peripherally to triiodothyronine (T3), which binds to thyroid hormone receptors in the cell nucleus to modulate gene transcription and protein synthesis, thereby restoring normal metabolic function.
$0.0BPart D
18.4 years to LOEMechanism of Action
synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins. The physiological actions of thyroid…
Indications (2)
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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.