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Aurobindo receives FDA approval for enalapril maleate oral solution

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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application enalapril maleate oral solution, 1 mg/mL Aurobindo Pharma’s enalapril maleate oral solution, are an AB-rated generic equivalent to the reference listed drug (RLD), Epaned Oral Solution, manufactured by Azurity Pharmaceuticals, Inc.

Enalapril maleate oral solution are indicated for the treatment of:
• Hypertension
• Symptomatic heart failure
• Asymptomatic left ventricular dysfunction

Enalapril maleate oral solution has an estimated market size of US $19.9 Million for the twelve months ending Nov 2023, as per IQVIA.


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