FDA Approves Vostally (ramipril) Oral Solution for the Treatment of Hypertension in Adults

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FDA Approves Vostally (ramipril) Oral Solution for the Treatment of Hypertension in Adults

Greenville, SC – July 31, 2025 – Rosemont Pharmaceuticals, Inc. announced that on July 23, 2025, the U.S. Food and Drug Administration (FDA) has approved Vostally (ramipril) Oral Solution, an angiotensin converting enzyme (ACE) inhibitor that offers once-daily dosing in an oral liquid form for patients who have difficulty swallowing.

Vostally is indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Additionally, in patients 55 years or older at high risk of developing a major cardiovascular event, Vostally is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. Also, in adult patients with post-myocardial infarction heart failure, Vostally is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure.

Vostally is contraindicated in patients with a history of angioedema or hypersensitivity to this product or any other ACE inhibitor and in patients with hereditary or idiopathic angioedema. Vostally is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Vostally within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor. Do not co-administer Vostally with aliskiren in patients with diabetes.

“We are proud to bring Vostally to physicians to treat patients who may benefit from an ACE inhibitor but whose difficulty swallowing a tablet creates a barrier to this kind of therapy,” said Jeff Bryant, President of Sabal Therapeutics, a Rosemont Company. “This oral liquid form of ramipril provides physicians with another option for treating patients.”

“This FDA approval of Vostally marks an important milestone in expanding treatment options for patients who have difficulty swallowing traditional tablets or capsules,” continued Mr. Bryant. “We are proud to support Rosemont’s commitment to delivering high-quality oral liquid medicines to the U.S. market and believe Vostally will provide a meaningful benefit to both patients and healthcare providers and payors.”

Vostally will be available later this year. Full Prescribing Information, including boxed warning and safety profile, is available at www.RosemontPharmaceuticals.com.

About Rosemont Pharmaceuticals

Rosemont Pharmaceuticals is a U.K. headquartered pharmaceutical company specialized in the development and commercialization of oral liquid medicines. Rosemont was founded more than 50 years ago and sells over 130 liquid products in more than 27 markets. In July 2024, Rosemont announced the acquisition of Sabal Therapeutics, a U.S. based pharmaceutical company, specialized in liquid medicines, thereby expanding their footprint into the U.S.

Source: Rosemont Pharmaceuticals

Posted : 2025-08-04 12:00

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