NDAINTRAVENOUSSOLUTION
Approved
Apr 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
5/8 — Partial
LEVOTHYROXINE SODIUM (levothyroxine sodium) by Fresenius Kabi is synthesis. First approved in 2019.
Drug data last refreshed 18m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Levothyroxine sodium is a synthetic thyroid hormone replacement therapy administered intravenously as a solution. It treats hypothyroidism and related thyroid disorders by replacing deficient endogenous thyroid hormone. The drug works by binding to thyroid receptor proteins in cell nuclei, activating gene transcription and stimulating cellular protein synthesis, with T3 (derived from T4 deiodination) producing the majority of physiological effects.
Peak10.4 years to LOE
Product is in peak commercial phase with established market presence; brand team size likely stable with focus on market penetration and clinical awareness.
Mechanism of Action
synthesis. Triiodothyronine (T3) and levothyroxine (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…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form
Started Jun 2019
72 enrolled
Healthy
Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors
Started Jul 2018
66 enrolled
Hypothyroidism;Postablative
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
Started Jul 2013
101 enrolled
Hypothyroidism
Career Relevance
Worked on LEVOTHYROXINE SODIUM at Fresenius Kabi? Share your interview experience or compensation data (+7 days Pro)
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.