NDAINTRAVENOUSPOWDER
Approved
Jun 2011
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
6/8 — Strong
LEVOTHYROXINE SODIUM (levothyroxine sodium anhydrous) by Fresenius Kabi is synthesis. Approved for myxedema coma. First approved in 2011.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Levothyroxine sodium anhydrous is a synthetic thyroid hormone (T4) replacement therapy administered intravenously as a powder formulation. It treats myxedema coma by restoring thyroid hormone levels and activating gene transcription through nuclear thyroid hormone receptors. The drug's effects are mediated primarily through peripheral conversion to T3, which binds thyroid receptors and restores critical metabolic and physiological functions.
Peak6.1 years to LOE
Peak-stage product with established market presence; team size likely stable with focus on efficacy maintenance and safety monitoring rather than growth expansion.
Mechanism of Action
synthesis. Triiodothyronine (T 3 ) and levothyroxine (T 4 ) 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 (1)
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
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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.