NDAINTRAVENOUSPOWDER
Approved
Jun 2011
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
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 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Levothyroxine sodium anhydrous is a synthetic thyroid hormone replacement therapy administered intravenously as a powder formulation. It is indicated for myxedema coma, a life-threatening emergency state of severe hypothyroidism. The drug works by binding to thyroid nuclear receptors to activate gene transcription, with T3 (derived from T4 deiodination) producing the predominant physiological effects.
Peak5.9 years to LOE
Peak lifecycle status suggests a mature, stable commercial program with established market presence and potentially modest team expansion opportunities.
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 (7)
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
Fasting Study of Levothyroxine Sodium Tablets 300 mcg to Synthroid® Tablets 300 mcg
Started Mar 2007
33 enrolled
Healthy
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
Started Aug 2005
32 enrolled
Healthy
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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.