Aventis has received confirmation from the U.S. Food and Drug Administration (FDA) that information posted on April 7, 2003, on the agency's Web site, listing a Paragraph IV Patent Certification for an Abbreviated New Drug Application (ANDA) for a generic version of Clexane /Lovenox (enoxaparin sodium injection), was published in error and that the listing has been removed. Aventis has not received any information on a Paragraph IV certification pertaining to Clexane/Lovenox.
A Paragraph IV certification is required to be provided by any party filing an ANDA (under Section 505(j) of the Food, Drug, and Cosmetic Act) relating to a drug for which a patent has been issued. A Paragraph IV certification is also required relating to an application under Section 505 (b)(2) where at least some of the information required for approval comes from studies not conducted by the applicant and for which the applicant has not obtained a right of reference. The Paragraph IV certification must state that the current patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the drug.
Clexane /Lovenox is the only low-molecular-weight heparin (LMWH) in the United States approved by the FDA for seven different clinical indications. Clexane /Lovenox is the most widely used and studied LMWH, with numerous national and international clinical studies demonstrating its safety and efficacy. Numerous clinical studies have demonstrated the product's benefits as a safe and effective way to significantly reduce the incidence of deep vein thrombosis in a wide range of patient populations, and as effective prophylaxis of ischemic complication of unstable angina (UA) and non-Q wave myocardial infarction (NQWMI) when administered concomitantly with aspirin. The safety and efficacy of Clexane /Lovenox is reflected by its use in the treatment of 100 million patients in 96 countries.