LEVOTHYROXINE SODIUM

Post-LOE

levothyroxine sodium

Accord Biopharma

ANDAORALTABLET

Approved

Oct 2020

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

LEVOTHYROXINE SODIUM (levothyroxine sodium) by Accord Biopharma is synthesis. Approved for hypothyroidism during the recovery phase of subacute thyroiditis, including neonates, an adjunct to surgery and 5 more indications. First approved in 2020.

Drug data last refreshed 18h ago

Mechanism 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 (8)

hypothyroidism during the recovery phase of subacute thyroiditis including neonates

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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.

Clinical Trials (3)

NCT04037748Phase 1Completed

Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form

Started Jun 2019

72 enrolled

Healthy

NCT03094416Phase 4Completed

Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

Started Jul 2018

66 enrolled

Hypothyroidism;Postablative

NCT01916304Phase 2Completed

Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation

Started Jul 2013

101 enrolled

Hypothyroidism