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Generic Version of Norvasc Receives Final Approval

PITTSBURGH, Pa., Oct. 4 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE:MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base). Amlodipine Besylate Tablets are the generic version of Pfizer's Norvasc(R) Tablets, which had U.S. sales of approximately $2.5 billion for the 12-month period ended June 30, 2005, according to IMS Health.

The FDA has confirmed that Mylan was the first generic company to file on all strengths of Norvasc(R) Tablets and is therefore eligible for 180 days of market exclusivity. The FDA has indicated that the exclusivity will begin to run from the earlier of the commercial launch of the Mylan product or a final court decision concerning the pending litigation between Pfizer and Mylan.

Source: Mylan Laboratories Inc.

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