FDA Approves Losartan Potassium for Reduction in Risk of Stroke
The new approval is an oral suspension for patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy.
The FDA approved losartan potassium (Arbli) as an oral suspension 10 mg/mL for the reduction in risk of stroke for patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy for some patients with type 2 diabetes. This approval became the first and only ready-to-use oral liquid losartan in the United States, according to a company news release.1
The new approval is an oral suspension for patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy. Image Credit: grinny | stock.adobe.com
“The approval of Arbli exemplifies our deep commitment to develop high-value products that address unique and underserved patient needs. A significant number of patients can benefit from a safe and efficacious ready-to-use oral liquid formulation of losartan. We are excited with the approval of our first brand product, which is part of our upcoming pipeline of novel specialty products,” Shankar Hariharan, PhD, CEO of Scienture, said in the news release.1
The new formulation makes administration easier and offers a safer, more convenient option, according to the news release. Current options are only in solid form, and the new approval does not require compounding, reducing dosing volume and long-term shelf-life. It will be offered in a 165-mL bottle, which will not require refrigeration, and has a shelf life of 18 months.1
The company was issued a patent for the intellectual property position. The patent covers the stable, liquid composition of the drug as well as the method of treating patients with losartan by the administration of the novel formulation.2
“The two issued patents demonstrate our accomplished development capabilities for novel products and our commitment to bring to market high-value products that address unique and underserved patient needs,” Hariharan added in a news release.2 “We are pleased to note that the NDA filed for SCN-102 is currently under review at the FDA.”
Losartan is an angiotensin receptor block that is approved by the FDA for a variety of conditions, and there are some off-label uses for Marfan syndrome, acute coronary syndrome, stable coronary artery disease, and intolerance to angiotensin-converting enzyme inhibitors, according to StatPearls.3
Regular monitoring of renal function and blood pressure by a health care team is needed, and losartan can be incorporated into long-term plans, according to the authors. After being prescribed, pharmacists should verify appropriate dosing, conduct medication reconciliation, and counsel patients on the therapy.3
