Amphastar files Amended Complaint against US FDA over Lovenox

Privately-held Amphastar Pharmaceuticals has filed with the US District Court for the District of Columbia an Amended Complaint for Declaratory and Injunctive Relief against the US Food and Drug Administration in company’s continuing battle to win approval of the its long-pending Abbreviated New Drug Application for a generic version of French drug major Sanofi-Aventis (Euronext: SAN) blockbuster anti-coagulant drug Lovenox (enoxaparin sodium injection), which generated sales of $4.57 billion for the latter firm in 2009.

The December 22, 2010, amended complaint follows Amphastar’s October 25 Complaint and November 5 Motion for Preliminary Injunction filed against the 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 the 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 the FDA’s release of the imported semi-purified heparin raw material and “expounds upon Amphastar’s broader claim of arbitrary and capricious actions by [the FDA],” comments US law firm Hyman, Phelps & McNamara on its FDA Law Blog. Amphastar alleges a litany of APA violations, including that the “FDA’s imposition of immunogenicity testing requirements on enoxaparin ANDAs is beyond the authority of the FDA,” and that the “FDA has treated Amphastar disparately from Amphastar’s similarly situated competitors.”