ARBLI (Losartan Potassium) Oral Suspension

Arbli (losartan potassium) is an angiotensin II receptor blocker (ARB) supplied as a ready-to-use oral suspension at 10 mg/mL. It is held under NDA 218772 by Scienture LLC, approved in March 2025 under the 505(b)(2) pathway.

NDA 218772 (Arbli (losartan potassium) oral suspension) was submitted and approved under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The sponsor is Scienture LLC, and the application was approved on March 13, 2025. The product is an oral suspension at a strength of 10 mg/mL. It is indicated for the treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old, where lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions; for the reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy, with evidence that this benefit does not apply to Black patients; and for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.

The same active ingredient was previously approved as NDA 020386 (Cozaar, losartan potassium tablets), approved in 1995 in 25 mg, 50 mg, and 100 mg tablet strengths and indicated for hypertension, reduction of stroke risk in patients with hypertension and left ventricular hypertrophy, and diabetic nephropathy in type 2 diabetic patients. Losartan was also previously approved in fixed-dose combination with hydrochlorothiazide as NDA 020387 (Hyzaar, losartan potassium/hydrochlorothiazide tablets), approved in 1995 in 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg tablet strengths and indicated for the treatment of hypertension. The current NDA 218772 differs in dosage form, providing losartan potassium as a ready-to-use oral suspension at 10 mg/mL rather than as a tablet, while relying on Cozaar (NDA 020386) as the listed drug and proposing the same indications, doses, and dosing regimen.

Per the prescribing information and the clinical pharmacology review, new bioavailability and food-effect studies were conducted to support the 505(b)(2) filing, and no new efficacy trials were performed; the application relies on FDA's prior findings of safety and effectiveness for Cozaar (NDA 020386). The relative bioavailability study (study 14323) compared a single oral dose of the losartan potassium oral suspension 10 mg/mL (10 mL, total dose 100 mg) to Cozaar 100 mg tablets under fasting conditions. The suspension was not bioequivalent to the tablets for the parent losartan, showing an approximately 35% higher Cmax, though AUC for losartan was equivalent and the parameters for the active metabolite (losartan carboxylic acid) fell within the 80.00%–125.00% acceptance range; the higher Cmax was judged not clinically significant given the flat dose-response relationship. A food-effect study (study 14324) showed that a high-fat, high-calorie meal slowed absorption and lowered Cmax but had minor effects on AUC, supporting administration with or without food. These studies formed the pharmacokinetic bridge to the listed drug.

Arbli is indicated for the following:

• Treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.
• Reduction of stroke risk in patients with hypertension and left ventricular hypertrophy. Note that this benefit does not apply to Black patients.
• Treatment of diabetic nephropathy with elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.

Arbli is supplied as a white, translucent oral suspension containing losartan potassium 10 mg/mL (equivalent to 9.2 mg losartan per mL), in a ready-to-use 165 mL HDPE bottle.

Per mL: Losartan potassium 10 mg (equivalent to 9.2 mg losartan)

Hypromellose, methyl paraben, natural peppermint flavor, polyethylene glycol, povidone, propyl paraben, propylene glycol, purified water, simethicone, sodium phosphates, sucralose, and xanthan gum.

Arbli doses are expressed in mg of losartan potassium and administered orally using an oral dosing syringe or dosing cup. Shake for 20 seconds before each use.

Adult Hypertension: The usual starting dose is 50 mg once daily, which may be increased to 100 mg once daily as needed. For patients with possible intravascular depletion, consider starting at 25 mg once daily.

Pediatric Hypertension (6–16 Years): The recommended dose is 0.7 mg/kg once daily (maximum 50 mg), titrated to blood pressure response. Doses above 1.4 mg/kg per day or greater than 100 mg/day have not been studied.

Hypertension with Left Ventricular Hypertrophy: Begin with 50 mg once daily. Hydrochlorothiazide 12.5 mg may then be added, and/or the Arbli dose increased to 100 mg once daily. If further response is needed, hydrochlorothiazide may be increased to 25 mg once daily.

Diabetic Nephropathy: The initial dose is 50 mg once daily, which may be increased to 100 mg once daily based on blood pressure response.

Hepatic Impairment (Mild-to-Moderate): A reduced starting dose of 25 mg once daily is recommended.

Arbli doses are expressed in mg of losartan potassium and administered orally using an oral dosing syringe or dosing cup. Shake for 20 seconds before each use.

Arbli is supplied as 165 mL of white, translucent oral suspension in an HDPE bottle with a child-resistant cap and tamper-evident seal.

Store at 20°C to 25°C (excursions permitted between 15°C and 30°C). Keep tightly closed and protect from light. Store and dispense in the original container. Once opened, use within 60 days. The approved expiry dating period is 18 months from the date of manufacture when stored at the recommended temperature.

The content below is an abbreviated summary drawn from the full prescribing information. It is meant to give a directional overview and should not be relied upon as comprehensive. Consult the full label for complete details.

Following oral administration, losartan is well absorbed and undergoes substantial first-pass metabolism, with a systemic bioavailability of approximately 33%. Peak concentrations are reached at about 1 hour for losartan and 2 hours for the active metabolite. A high-fat, high-calorie meal slows absorption and reduces peak concentrations, but has only minor effects on overall exposure (AUC). This supports administration with or without food.

Both losartan and its active metabolite are highly protein bound, primarily to albumin. The terminal half-life is approximately 2 hours for losartan and 6 hours for the active metabolite. No accumulation occurs with once-daily dosing. Losartan is partly metabolized to an active carboxylic acid metabolite (approximately 14% of an oral dose) via CYP2C9 and CYP3A4, with elimination occurring through renal and biliary routes.

For NDA 218772, a relative bioavailability study (Study 14323) and a food-effect study (Study 14324) were conducted to bridge to the listed drug. The suspension was not bioequivalent to Cozaar tablets for losartan Cmax (higher with the suspension), while AUC for losartan was similar and active-metabolite pharmacokinetics were comparable. The food-effect study showed slowed absorption and reduced Cmax with minor AUC impact, supporting administration with or without food.

The content below is an abbreviated summary drawn from the full prescribing information. It is meant to give a directional overview and should not be relied upon as comprehensive. Consult the full label for complete details.

Clinical efficacy for the approved indications is supported by the established losartan evidence base referenced in the labeling. This includes hypertension studies that enrolled pediatric patients aged 6 to 16 years, the LIFE outcomes study in hypertensive patients with left ventricular hypertrophy comparing losartan to atenolol, and the RENAAL study in type 2 diabetes with nephropathy comparing losartan to placebo on a background therapy regimen.