FDA Opposes Mylan & Apotex Reconsideration Motions on Amlodipine Besylate; FDA Declines to Immediately Approve Apotex ANDA

May 11, 2007

Last week we reported on motions submitted by Mylan and Apotex requesting that the U.S. District Court for the District of Columbia reconsider its April 30, 2007 memorandum opinion concerning 180-day generic drug and pediatric exclusivity issues involving NORVASC (amlodipine besylate) Tablets and the availability of generic versions of the drug product.  Mylan’s amlodipine drug product is the only generic version of NORVASC currently approved by FDA.

Apotex claims in its reconsideration motion that the company was successful in having the district court injunction lifted by a March 29, 2007 order entered by the U.S. District Court for the Northern District of Illinois, and that because of this order, FDA should immediately approve Apotex’s ANDA.  Mylan’s motion for reconsideration takes issue with FDA’s interpretation of FDC Act § 505A(c)(2) with respect to the applicability of Pfizer’s pediatric exclusivity to other generic applicants. 

On May 8, 2007, FDA filed a memorandum in opposition to the Mylan and Apotex requests.  With respect to Mylan’s claims, FDA argues that “Mylan’s brief adds nothing new that requires reconsideration,” and that the court should deny the company’s reconsideration request.  With respect to Apotex, FDA refers to a May 7, 2007 letter answer the Agency sent to the company.  In that letter, FDA declines to immediately approve Apotex’s amlodipine ANDA.  FDA’s letter states:

The issuance of the March 29 Order by the Illinois district court does not change the result under the above analysis or entitle Apotex to immediate approval.  Pediatric exclusivity will continue to bar approval of Apotex’s ANDA until Apotex affirmatively wins its patent litigation, with a final effective decision that the patent is invalid or not infringed.  The March 29 Order is not a final effective decision that the patent is invalid or not infringed.  Lifting the injunction does not by itself convert the original Illinois district court finding the ‘303 patent is valid and infringed into a finding that the patent is invalid or not infringed.  Either the Illinois district court’s original judgment that the patent is valid and infringed remains in effect until the mandate issues, or, at best, the lifting of the injunction nullified that court’s initial decision so that there is in effect no district court judgment.  Under either scenario, Apotex has not obtained a final effective court determination that the patent is invalid such that pediatric exclusivity has ceased to bar approval of Apotex’s ANDA.

Both Mylan and Apotex have submitted briefs contesting FDA’s May 8, 2007 opposition memorandum. 

Categories: Hatch-Waxman