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Watson Laboratories generic Lotrel ANDA gets FDA approval

Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has got the US Food and Drug Administration approval for its abbreviated new drug application (ANDA) for Amlodipine Besylate/Benazepril 5/20mg, 10/20mg, 2.5/10mg, and 5/10mg capsules.

Watson claims that its Amlodipine Besylate/Benazepril capsules are generic equivalent to Novartis’ Lotrel capsules, which are indicated to prevent and treat high blood pressure.

Lotrel is a combination medicine that is used when treatment with a single drug has not been successful or has caused side effects.

Lotrel’s component, amlodipine, is a calcium channel blocker. It eases the workload of the heart by slowing down the passage of nerve impulses and hence the contractions of the heart muscle.