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Aurobindo gets tentative US FDA nod for Perindopril Erbumine & Ecitalopram Oxalate
Our Bureau, Mumbai | Friday, December 5, 2008, 08:00 Hrs  [IST]

Aurobindo Pharma Limited has received tentative approvals from the US Food & Drug Administration (US FDA) for perindopril erbumine tablets 2mg, 4mg, 8mg and escitalopram oxalate oral solution 5mg (base)/ 5ml.

Perindopril erbumine tablets are the generic equivalent of Solvay Pharmaceuticals Aceon tablets, falls under the CVS segment and indicated for the treatment of patients with essential hypertension.

Escitalopram oxalate oral solution are the generic equivalent of Forest Laboratories' Lexapro oral solution, falls under the CNS segment and indicated for the treatment of major depressive disorder.

Aurobindo now has 85 approved ANDAs from the US FDA (61 final approvals, 24 tentative approvals).

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