FDA Approves Generic Version of Blood Pressure Medication

 

October 15, 2010

October 15, 2010 – The U.S. Food and Drug Administration (FDA) has approved an abbreviated new drug application (ANDA) for a generic equivalent to Novartis’ Lotrel capsules.

Watson Laboratories, a subsidiary of Watson Pharmaceuticals, received the approval for Amlodipine Besylate/Benazepril 5/20mg, 10/20mg, 2.5/10mg, and 5/10mg capsules, which will be used to prevent and treat high blood pressure.

The ANDA was acquired as part of Watson's acquisition of the Arrow Group. The company intends to begin shipping the product immediately.

Lotrel capsules and its generic equivalents had total U.S. sales of approximately $1.05 Billion for the twelve months ending June 30, 2010, according to IMS Health.

For more information: www.watson.com

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