Rosemont Pharmaceuticals, Inc. has recently announced that the U.S. Food and Drug Administration (FDA) approved VOSTALLY (ramipril) Oral Solution on July 23, 2025. This is a new formulation of a widely used angiotensin-converting enzyme (ACE) inhibitor. This approval represents a significant advancement for patients with hypertension who have difficulty swallowing traditional solid dosage forms of drugs, such as tablets or capsules.
VOSTALLY can be taken once a day, providing the same clinical benefits as ramipril. It is specifically designed for adult patients who struggle with oral solid dosage forms. It is intended for adult patients who need to take medication for high blood pressure, a critical factor in reducing the risk of serious cardiovascular events, including stroke and heart attack.
In addition to controlling blood pressure, VOSTALLY is also indicated for other cardiovascular indications. In adults aged 55 and older, who are at increased risk of a major cardiovascular event, the medication helps reduce the risk of myocardial infarction, stroke, or cardiovascular death. It is also approved for use in adults recently recovering from heart failure to reduce both mortality and hospitalizations related to heart failure.
Despite its benefits, VOSTALLY carries certain contraindications. It should not be used in patients with a history of angioedema, hypersensitivity to ACE inhibitors, or hereditary or idiopathic angioedema. Additionally, it should not be used within 36 hours of taking sacubitril or used in combination with aliskiren in diabetic patients due to the risk of severe adverse reactions. A full 36-hour washout period is also required when transitioning to or from sacubitril/valsartan.
Commenting on the launch, Jeff Bryant, President of Sabal Therapeutics, a Rosemont company, emphasized the product’s role in addressing a key treatment barrier. “We are excited to launch VOSTALLY for healthcare providers treating patients who may benefit from ACE inhibitor therapy but struggle with swallowing pills,” said Bryant. “The liquid form offers an important new option in hypertension management.”
Bryant also noted the broader significance of the FDA approval. “This approval is an important step in access to effective cardiovascular medications. Rosemont is dedicated to providing high-quality oral liquid therapies to the U.S. healthcare market, and we believe VOSTALLY will deliver meaningful value to patients, clinicians, and payors.”
With the FDA’s approval, VOSTALLY is expected to become a valuable new option for managing hypertension and cardiovascular risk, especially for patient populations with specific administration needs.
References: Rosemont Pharmaceuticals. FDA approval of VOSTALLY® (ramipril) oral solution for the treatment of hypertension in adults. Published July 31, 2025. Accessed August 5, 2025. https://rosemontpharmaceuticals.com/wp-content/uploads/2025/07/Vostally-Press-Release-07-31-2025.pdf
