Mylan's generic version of Novartis' Lotrel for hypertension approved by FDA

By Lisa Kerner

Charlotte, N.C., July 13 - Mylan Laboratories Inc. said the Food and Drug Administration granted tentative approval for its abbreviated New Drug Application for Amlodipine Besylate and Benazepril Hydrochloride Capsules, 2.5 mg (base)/10 mg, 5 mg (base)/10 mg, 5 mg (base)/20 mg and 10 mg (base)/20 mg for the treatment of hypertension.

The capsules are the generic version of Novartis' Lotrel Capsules, which had annual U.S. sales of about $1.3 billion for the 12 months ended March 31, according to a company news release.

Located in Pittsburgh, Pa., Mylan develops, licenses, manufactures, markets and distributes generic and proprietary products.

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