FDA Decides Not to Approve Additional Amlodipine ANDAs at This Time

April 18, 2007

Earlier today, FDA issued its decision with respect to amlodipine generics and the applicability of Mylan’s 180-day exclusivity and Pfizer’s pediatric exclusivity.  The U.S. District Court for the District of Columbia in Mylan v. Leavitt had ordered FDA to respond to Mylan’s TRO motion by April 18, 2007.  According to FDA’s notice to the court, “FDA has decided not to approve ANDAs other than Mylan’s at this time.”  FDA’s 14-page decision letter accompanying the notice concludes that:

·        All of the unapproved ANDAs are currently blocked by Pfizer’s pediatric exclusivity.

·        If and when the mandate effectuating the panel’s March 22 decision issues in the Apotex case, Apotex’s ANDA will not be blocked by Pfizer’s pediatric exclusivity.

·        FDA cannot determine on the current record whether other ANDAs will continue to be blocked by pediatric exclusivity at this time.

·        Mylan’s 180-day marketing exclusivity terminated when the patent expired.

It is unclear at this time what action generic applicants other than Mylan might take to challenge FDA’s decision.  We will continue to update you on this developing story.


·        April 10, 2007 FDA Law Blog Post

Categories: Hatch-Waxman