Vostally FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 3, 2025.

FDA Approved: Yes (First approved July 23, 2025)
Brand name: Vostally
Generic name: ramipril
Dosage form: Oral Solution
Company: Rosemont Pharmaceuticals Inc.
Treatment for: High Blood Pressure, Cardiovascular Risk Reduction

Vostally (ramipril) is an oral solution formulation of the approved angiotensin converting enzyme (ACE) inhibitor ramipril used for the treatment of hypertension and to reduce the risk of cardiovascular events.

• 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.
  - 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.
  - In adult patients with post-myocardial infarction heart failure to reduce the risk of cardiovascular death and hospitalization for heart failure.
• Ramipril was first approved under the brand name Altace in an oral capsule formulation in 1991, and an oral tablet formulation in 2007. Both formulations of the brand are now discontinued, but generic versions of Altace capsules are still available.
• Vostally provides a treatment option for patients who have difficulty swallowing tablets or capsules.
• Vostally is administered orally once or twice daily.
• Warnings and precautions associated with Vostally include an increased risk of angioedema in patients with a prior history, hypotension, rare cholestatic jaundice and hepatic failure, renal impairment, and hyperkalemia.
• Common adverse reactions include cough and hypotension.

Development timeline for Vostally

Further information

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