To (b)(2) or Not to (b)(2)? That is no Longer the Question for Novartis and LOTREL

June 5, 2007

We previously reported that Pfizer submitted a citizen petition (2007P-0110) and a petition for stay of action (2007P-0111) requesting that FDA take certain action with respect to Novartis’s LOTREL (amlodipine besylate; benazepril HCl) subsequent to Pfizer’s decision to revoke (as of midnight March 25, 2007) the right of reference granted to Novartis to rely on data supporting the approval of Pfizer’s NORVASC (amlodipine besylate).  The right of reference Pfizer granted permitted Novartis to submit a “stand alone” 505(b)(1) NDA instead of a 505(b)(2) application. 

Specifically, Pfizer’s petition requests that FDA deem the LOTREL NDA a 505(b)(2) application subject to Pfizer’s pediatric exclusivity for amlodipine besylate (expiring on September 25, 2007), rescind final approval of the LOTREL NDA and reclassify it as a tentative approval, and withhold final approval of any NDA supplement for LOTREL.  Pfizer’s petition for stay of action requests that FDA stay the approval of any LOTREL NDA supplements concerning amlodipine besylate until September 25, 2007.

On May 18, 2007 (the same day that FDA approved the first generic version of LOTREL), FDA denied Pfizer’s citizen petition and petition for stay of action.  FDA’s response states that the “threshold issue in this matter is whether the termination of a right of reference to data that was necessary for approval of an NDA requires that the Agency withdraw approval of the NDA,” but notes that the “plain language of the FDCA does not address this question,” and that Pfizer “asserted no basis on which [FDA] may withdraw approval of the Lotrel NDA.”  “In the absence of such authority, [FDA] will not withdraw the Lotrel approval . . . .  Because we are not withdrawing the final approval of the Lotrel NDA, as either a 505(b)(1) application or a 505(b)(2) application, we do not need to address the issue of whether the Lotrel NDA is subject to Pfizer’s pediatric exclusivity for amlodipine.”

FDA’s decision, however, is not a total win for Novartis.  Pfizer’s decision to revoke the right of reference granted to Novartis may have significant implications on future submissions to the LOTREL NDA.  FDA’s May 18th response states:

As of March 25, 2007 . . .  FDA may not rely on data and information contained in the Norvasc NDA to approve supplements to the Lotrel application.  Therefore, the approval of any section 505(b)(1) supplement to the Lotrel NDA must be based on data owned by Novartis, or to which Novartis has a right of reference.  A section 505(b)(2) supplement would require appropriate patent and exclusivity certifications, and approval of such supplement could be delayed by patent or exclusivity protections.

Categories: Hatch-Waxman