MYLAN RECEIVES TENTATIVE APPROVAL FOR HYPERTENSION DRUG

Mylan Laboratories announced that the FDA granted tentative approval for its abbreviated new drug application for Amlodipine Besylate and Benazepril Hydrochloride Capsules in dosages of 2.5 mg (base)/10 mg, 5 mg (base)/10 mg, 5 mg (base)/20 mg and 10 mg (base)/20 mg.

Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension. They are the generic version of Novartis' Lotrel Capsules, which had annual U.S. sales of approximately $1.3 billion for the 12 months ending in March.