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New Amlodipine Salt Approved for U.S. Market

Cheryl Thompson

Dr. Reddy's Laboratories recently announced that the Food and Drug Administration (FDA) had approved the marketing of the company's amlodipine maleate product, known as AmVaz.

According to FDA, the amlodipine maleate tablets contain the equivalent of 2.5, 5, or 10 mg of amlodipine.

Neither Dr. Reddy's nor FDA has stated whether amlodipine maleate tablets will be marketed for the same indications as amlodipine besylate tablets, a product owned by Pfizer Inc. and sold under the brand name Norvasc.

The FDA-approved labeling for Norvasc states that amlodipine besylate is used for the treatment of hypertension, chronic stable angina pectoris, and Prinzmetal's angina.

In the press release announcing the approval of AmVaz, Dr. Reddy's said it had not decided on the date when the product would become available in the United States.

Not mentioned in the press release is a court case in which Pfizer seeks to stop Dr. Reddy's from marketing amlodipine maleate. Lawyers for the companies argued before the U.S. Court of Appeals for the Third Circuit in July. The case is pending.

The current legal action followed the December 2002 decision by a federal district court dismissing Pfizer's lawsuit, which alleged patent infringement by Dr. Reddy's new drug application for amlodipine maleate.