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FDA approves Lupin hypertension drug

The US Food and Drug Administration (FDA) has approved Lupin Pharmaceuticals' (LPI) abbreviated new drug application (ANDA) for amlodipine / benazepril 5mg/40mg, and 10mg/40mg capsules.

With this approval, the company has received approval for its complete product line of amlodipine / benazepril.

The US subsidiary of Lupin Limited, LPI’s amlodipine / benazepril capsules are the AB-rated generic equivalent to Lotrel capsules of Novartis, indiacted as a treatment of hypertension.

Lotrel contains a combination of amlodipine and benazepril.