FDA confirms Mylan's version is only approved amlodipine

April 30, 2007

The FDA has confirmed Mylan's current status of having the only approved ANDA for all strengths of amlodipine besylate, which is a generic version of Pfizer's Norvasc

Pittsburgh-based Mylan Laboratories announced that the FDA has confirmed Mylan's current status of having the only approved ANDA for all strengths of amlodipine besylate, which is a generic version of Pfizer's Norvasc. The FDA notified Mylan and other amlodipine besylate ANDA applicants that all of the unapproved amlodipine besylate applications are currently blocked from approval by pediatric exclusivity and, if the mandate from the March 21 appellate court decision related to the validity of the amlodipine besylate patent does not issue before Sept. 25, "Pfizer and Mylan will have no additional competition during the interim period and thus will obtain the full benefit that could be derived under pediatric and 180-day marketing exclusivity." The FDA also stated that in the event an appellate court mandate is issued prior to Sept. 25, the only ANDA eligible for approval during that period will be from Apotex because of the favorable court decision in the Pfizer case. Mylan will continue to assert that even Apotex should either be blocked by Mylan's 180-day exclusivity or not be approved during the pediatric exclusivity period based on multiple prior FDA rulings.

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