Arbli FDA Approval History
Last updated by Judith Stewart, BPharm on March 18, 2025.
FDA Approved: Yes (First approved March 13, 2025)
Brand name: Arbli
Generic name: losartan potassium
Dosage form: Oral Suspension
Company: Scienture Holdings, Inc.
Treatment for: High Blood Pressure, Diabetic Kidney Disease
Arbli (losartan potassium) is an oral liquid formulation of the approved angiotensin II receptor blocker losartan for use in the treatment of hypertension and diabetic nephropathy.
- Arbli is indicated for:
- treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients.
- treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. - Arbli contains losartan, a well established and proven therapy for treating hypertension. Losartan was first approved in a tablet formulation under the brand name Cozaar in 1995, and is widely available as a generic.
- Losartan is an angiotensin II receptor blocker (ARB) that works by blocking the effect of angiotensin II (a potent vasoconstrictor) to dilate the blood vessels and lower blood pressure.
- Arbli is the first FDA approved, ready-to-use, oral liquid formulation of losartan. Previously patients who required a liquid formulation of losartan would have received an extemporaneously compounded preparation from crushed tablets. Arbli provides a safe and convenient option to patients who require a liquid formulation, while addressing the intrinsic risks associated with potential inconsistencies in the process of extemporaneous compounding.
- Arbli comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration. It has been approved for a shelf life of 18 months from the date of manufacture when stored at room temperature. The shelf-life of the product is expected to be extended to 24-months at room temperature once the 24-month stability data is submitted to the FDA.
- Arbli is administered orally once daily.
- Arbli comes with a Boxed Warning for fetal toxicity. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Warnings and precautions associated with Arbli include hypotension.
- Common adverse reactions (incidence ≥2% and greater than placebo) include dizziness, upper respiratory infection, nasal congestion, and back pain.
Development timeline for Arbli
| Date | Article |
|---|---|
| Mar 18, 2025 | Approval FDA Approves Arbli (losartan potassium) Oral Suspension as the First Ready-to-Use Oral Liquid Losartan in the U.S. |
Further information
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