FDA confirms Mylan's status as only approved ANDA for all strengths of Amlodipine Besylate tablets

Apr 20 2007

Mylan Laboratories has 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 pediatric and 180-day marketing exclusivity."

The FDA further stated that in the event an appellate court mandate is issued prior to September 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.

Amlodipine Besylate Tablets are the generic version of Pfizer's Norvasc(R) Tablets, which had U.S. sales of approximately $2.7 billion for the 12-month period ending Dec. 31, 2006, according to IMS Health.