FDA Confirms Mylan's Status as the Only Approved ANDA for all Strengths of Amlodipine Besylate Tablets

Mylan Laboratories Inc. (NYSE:MYL) announced that the U.S. Food and Drug Administration (FDA) has confirmed Mylan's current status as the only approved ANDA for all strengths of Amlodipine Besylate Tablets. The FDA notified Mylan and all amlodipine besylate ANDA applicants that all of the unapproved amlodipine besylate ANDAs 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 September 25, 2007, "Pfizer and Mylan will have no additional competition during the interim period and thus will obtain the full benefit that could be derived under...

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