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Mylan confirms potential first-to-file ANDA on Pfizer's Norvasc

PITTSBURGH, PA., - October 16, 2002 -- Robert J. Coury, Vice Chairman and CEO of Mylan Laboratories acknowledged that Mylan has filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to sell amlodipine besylate tablets (a generic version of Norvasc ) prior to the expiration of patents owned by Pfizer Inc.

Pfizer filed suit against Mylan, but not before the expiration of the 45 day statutory period, meaning the FDA can approve Mylan's ANDA as soon as the agency determines that all regulatory requirements have been satisfied.

Robert Coury believes that Mylan is the first to file an amlodipine ANDA containing a "paragraph IV" certification. However, FDA policy prohibits the Agency from confirming first-to-file status until an application receives final approval.

Mr. Coury took exception to comments made by Pfizer regarding the merits of Mylan's amlodipine patent challenge: "Contrary to Pfizer's comments, Mylan has been very selective in choosing which patents to challenge in these cases."

He further stated that "it has been eighteen years since the Hatch- Waxman amendments became law, and during this period Mylan has been very successful in challenging patents and bringing high quality generic products to market sooner than would have otherwise been possible. You don't enjoy that kind of success unless your legal positions are consistently meritorious.

"Consumers have enjoyed tens of billions of dollars in savings as a result of the success of Mylan and other generic companies, and they will continue to reap these savings as we go forward."

"Mylan, which has its own line of branded products and an expanding patent portfolio respects the valid intellectual property rights of others and appreciates the importance of rewarding and protecting truly novel discoveries which advance medical science" stated Coury.

Source: Mylan Laboratories

Posted: October 2002