FDA approves Epaned for treatment of symptomatic and asymptomatic heart failure

Silvergate Pharmaceuticals, Inc. (www.Silvergatepharma.com), focused on the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved Epaned® (enalapril maleate Powder for Oral Solution) for the treatment of symptomatic heart failure and the treatment of asymptomatic left ventricular dysfunction (to decrease the rate of development of overt heart failure and to reduce hospitalization for heart failure). These indications are in addition to the prior approval for hypertension (high blood pressure) in patients older than 1 month.

"Now with 3 indications, Epaned is available to help more patients who need the proven benefits of enalapril in an FDA-approved powder for oral solution, thereby ensuring that they are receiving a medicine that meets the highest quality standards," said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc.

Epaned delivers trusted efficacy. The effectiveness of enalapril has been well established in clinical trials. With its unique formulation, Epaned provides a consistent potency in each dose. Epaned also offers the quality of a product made in accordance with FDA regulations and requirements.

Silvergate is committed to helping patients and caregivers by making sure that Epaned is affordable and accessible to all patients. Epaned is widely available at patients' local pharmacies and is covered by the vast majority of commercial payers. Epaned is also reimbursed by Medicaid in every state. Co-pay support and patient assistance are available for qualifying patients.