Sanofi-aventis announced that the US District Court for the District of Columbia has denied the company’s request for preliminary injunctive relief against the FDA. The Court has not ruled on the merits of the company’s suit against the FDA regarding the approval of the Sandoz enoxaparin ANDA. As a result of this ruling, the generic version of enoxaparin can continue to be marketed in the US.
The company’s case against the FDA will continue to move forward, even without preliminary injunctive relief. Sanofi-aventis believes that this case poses a number of significant questions regarding the FDA review process for complex pharmaceutical products which are important to pursue.
Sanofi-aventis is committed to making healthcare professionals aware of the complexities related to the biologic composition and manufacturing of Lovenox so that they can make informed decisions about treatment options for their patients. Pending a final decision on the merits of the underlying complaint, sanofi-aventis will continue to make original enoxaparin (Lovenox) available to healthcare professionals for their patients.
Lovenox is an anticoagulant of complex biological nature obtained by fractionation of heparin. Lovenox consists of a highly complex set of heterogeneous sugars (polysaccharides) derived from biological material and resulting from a strictly controlled manufacturing process. The structure, pharmacological properties, and clinical properties of Lovenox are highly dependent on its manufacturing process. To date, the active ingredients of Lovenox cannot be fully characterized by a scientifically validated technology. In fact, the precise mechanisms by which it derives its safety and efficacy properties have yet to be fully elucidated.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone.