LEVOTHYROXINE SODIUM

Post-LOE

levothyroxine sodium anhydrous

MAIA Biotechnology

ANDAINTRAVENOUSPOWDER

Approved

Dec 2018

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

LEVOTHYROXINE SODIUM (levothyroxine sodium anhydrous) by MAIA Biotechnology is synthesis. Approved for myxedema coma. First approved in 2018.

Drug data last refreshed 20h ago

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)

myxedema coma

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

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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.