FDA approves Silvergate’s Qbrelis

The FDA has approved Silvergate's Qbrelis.
The FDA has approved Silvergate's Qbrelis. | shutterstock

The U.S. Food and Drug Administration (FDA) has approved Silvergate Pharmaceuticals’ Qbrelis Oral Solution, the first Lisinopril oral solution that has been approved by the agency. 

Silvergate is a leader in developing and commercializing safe, groundbreaking medications for children. Qbrelis was designed to treat high blood pressure (hypertension) in adult and pediatric patients, adjunct therapy for heart failure and acute myocardial infarction in adults.

"We are excited to launch our second product focused on pediatric patients and pediatric hypertension," Silvergate Pharmaceutical President and CEO Frank Segrave said. "Qbrelis provides a ready-to-use oral solution for these children with the additional assurance of an FDA-approved medication. As a company, we continue to focus on pediatric medications that are safe, effective, and readily available."

In children six years of age or older, Qbrelis allows for dosing based on weight, rather than adjusted adult doses, which was the norm until now. Qbrelis will be made available to patients through pharmacies and qualified mail order services.