FDA

FDA OKs losartan oral suspension

March 20, 2025

FDA approved Arbli (losartan potassium 10 mg/mL), an angiotensin II receptor blocker, for the following indications:

• treatment of hypertension, to lower BP in adults and children >6 years of age
• reduction of stroke risk in patients with hypertension and left ventricular hypertrophy
• treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with T2DM and a history of hypertension

Safety

The most common adverse effects (incidence ≥2% and greater than placebo) are: dizziness, upper respiratory tract infection, nasal congestion, and back pain.

Sources:

Scienture. Arbli (losartan potassium suspension) [package insert]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218772s000lbl.pdf Revised March 2025. Accessed March 19, 2025.

Scienture announces the US FDA approval of its NDA for SCN-102, to be launched as ArbliTM, (losartan potassium) Oral Suspension, 10mg/mL. The global market for losartan potassium was approximately $1.5 billion in sales in 2024. Scienture. 2025. https://scienture.com/news/scienture-announces-the-u-s-fda-approval-of-its-nda-for-scn-102-to-be-launched-as-arblitm-losartan-potassium-oral-suspension-10mg-ml-the-global-market-for-losartan-potassium-was-approximately/