HemiClor FDA Approval History
Last updated by Judith Stewart, BPharm on May 6, 2025.
FDA Approved: Yes (First approved March 17, 2025)
Brand name: HemiClor
Generic name: chlorthalidone
Dosage form: Tablets
Company: PRM Pharma, LLC
Treatment for: High Blood Pressure
HemiClor (chlorthalidone) is a thiazide-like diuretic indicated for the treatment of hypertension in adults, to lower blood pressure.
- Lowering blood pressure in patients with hypertension reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- HemiClor contains chlorthalidone, a well established medicine for use in the treatment of hypertension that was first approved in 1960 under the brand name Hygroton. Hygroton tablets were originally approved in 25 mg and 50 mg strengths, and although the brand is now long discontinued, generic versions are widely available.
- Chlorthalidone is recognized in the 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults as the preferred diuretic based on its prolonged half-life and evidence of cardiovascular outcome benefits. Studies have demonstrated that stepped-care treatment strategies, often beginning with 12.5 mg of chlorthalidone, were effective in reducing the risk of cardiovascular events. These findings support the use of 12.5 mg as the recommended starting dose in current hypertension treatment guidelines, either to initiate antihypertensive therapy or to serve as add-on therapy when additional blood pressure reduction is needed.
- HemiClor is a low-dose formulation of chlorthalidone supplied as 12.5 mg tablets, providing patients and healthcare professionals access to a formulation that aligns with the guideline recommendations.
- HemiClor tablets are administered orally, once daily. The dose may be increased as needed based on individual response.
- Warnings and precautions associated with HemiClor include increased risk of acute kidney injury in patients with pre-existing kidney disease; electrolyte abnormalities; metabolic disturbances; and systemic lupus erythematosus.
- The most frequently expected adverse drug reactions among patients receiving thiazide-like diuretics are electrolyte abnormalities and metabolic disturbances.
Development timeline for HemiClor
| Date | Article |
|---|---|
| Apr 16, 2025 | Approval FDA Approves HemiClor (chlorthalidone) for the Treatment of Hypertension |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.