Aurobindo Pharma Limited, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received tentative approvals from the US Food and Drug Administration (US FDA) for perindopril erbumine tablets in 2mg, 4mg and 8mg strengths, and escitalopram oxalate oral solution in 5ml strength.
These new tentative nods take Aurobindo’s approved abbreviated new drug applications (ANDAs) from the US FDA to 85 – 61 final approvals and 24 tentative approvals, the company stated in a press release on Friday.
Perindopril erbumine tablets are the generic equivalent of Solvay Pharmaceuticals’ Aceon tablet,s which fall under the cardiovascular system (CVS) segment indicated for the treatment of patients with essential hypertension, while Escitalopram oxalate oral solution is the generic equivalent of Forest Laboratories’ Lexapro oral solution, which falls under the central nervous system (CNS) segment and indicated for the treatment of major depressive disorder.
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