Here We Go Again . . . . Amphastar Renews Generic LOVENOX Case Against FDA

By Kurt R. Karst –      

Amphastar Pharmaceuticals Inc. (“Amphastar”) has filed with the U.S. District Court for the District of Columbia an Amended Complaint for Declaratory and Injunctive Relief against FDA in Amphastar’s continuing battle to win approval of the company’s long-pending Abbreviated New Drug Application (“ANDA”) for a generic version of sanofi-aventis U.S. L.L.C.’s (“sanofi’s”) blockbuster anti-coagulant drug LOVENOX (enoxaparin sodium injection).  The December 22nd amended complaint follows, as we previously reported (here and here), Amphastar’s October 25th Complaint and November 5th Motion for Preliminary Injunction filed against FDA with regard to the Agency’s detention of two entries of semi-purified heparin, the starting material for Enoxaparin Sodium.  That issue was resolved after FDA released the raw material. 

Amphastar’s Amended Complaint, like the company’s original Complaint, alleges violations of the Administrative Procedure Act (“APA”).  The Amended Complaint accounts for the factual change arising from FDA’s release of the imported semi-purified heparin raw material and “expounds upon Amphastar’s broader claim of arbitrary and capricious actions by [FDA].”  Amphastar alleges a litany of APA violations, including that “FDA’s imposition of immunogenicity testing requirements on enoxaparin ANDAs is beyond the authority of the FDA,” and that “FDA has treated Amphastar disparately from Amphastar’s similarly situated competitors.”

Amphastar’s battle with FDA is not the only current case concerning Enoxaparin Sodium.  In a different case pending in the D.C. District Court, sanofi is challenging FDA’s approval of Sandoz Inc.’s ANDA No. 77-857 for generic LOVENOX, as well as FDA’s July 23rd response to a February 2003 citizen petition, in which the Agency outlined the five criteria (i.e., standards for identity) that an ANDA applicant needs to demonstrate sameness of its active ingredient as compared to LOVENOX.  As we recently reported, sanofi filed a Motion for Summary Judgment alleging that FDA’s approval of ANDA No. 77-857 is unlawful and should be set aside.  Among other things, sanofi alleges that FDA exceeded its authority under FDC Act § 505(j)(2)(A) by requiring Sandoz to submit studies beyond what is permitted for ANDAs – specifically, immunogenicity studies that, according to Sanofi, are studies intended “to demonstrate safety and effectiveness.”