Regulatory Actions

Teva Announces Approval of Amlodipine Besylate Tablets

Published in Medical Letter on the CDC and FDA, July 22nd, 2007

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration (FDA) has granted approval for the company's ANDA for Amlodipine Besylate Tablets, 2.5 mg, 5 mg and 10 mg. Shipment of the product will begin shortly.

Teva's Amlodipine Besylate Tablets are the AB rated generic equivalent of Pfizer's Norvasc(R) Tablets, and are indicated for treatment of hypertension, chronic stable angina and vasospastic angina. Mylan has sued the FDA arguing that its 180-day exclusivity blocks other final approvals until September, 2007.

Total annual sales of this product are approximately $2.8 billion for the twelve...

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Source: Medical Letter on the CDC and FDA (2007-07-22)

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