CYTOMEL
Details
- Status
- Prescription
- First Approved
- 1956-05-08
- Routes
- ORAL
- Dosage Forms
- TABLET
CYTOMEL Approval History
What CYTOMEL Treats
3 indicationsCYTOMEL is approved for 3 conditions since its original approval in 1956. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypothyroidism
- Thyroid Cancer
- Hyperthyroidism
CYTOMEL Boxed Warning
NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS • Thyroid hormones, including CYTOMEL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. • In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. • Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for the...
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS • Thyroid hormones, including CYTOMEL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. • In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. • Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects [see Adverse Reactions (6) , Drug Interactions (7.7) , and Overdosage (10) ] . WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning. • Thyroid hormones, including CYTOMEL, should not be used for the treatment of obesity or for weight loss. • Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity ( 6 , 7.7 , 10 ).
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CYTOMEL FDA Label Details
ProIndications & Usage
FDA Label (PDF)CYTOMEL is an L-triiodothyronine (T3) indicated for: • Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism • Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer • Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy Limitations of Use : - Not indicated for suppression of benign thyroid nodules and nontoxic ...
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS • Thyroid hormones, including CYTOMEL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. • In euthyroid patients, doses within the range of daily hormonal requirements are ineffe...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.