FDA Advisory C'tee Recommendation For R-PR's Lovenox

Franco-American firm Rhone-Poulenc Rorer says the US Food and DrugAdministration's Cardiovascular and Renal Drugs Advisory Committee has recommended approval of its injectable Lovenox (enoxaparin sodium) for the treatment of unstable angina and non-Q-wave myocardial infarction.

R-PR, which is seeking marketing clearance for Lovenox to be administered with aspirin to treat unstable angina and heart attack, says this is the first low-molecular-weight heparin to gain FDA advisory committee recommendation for a cardiovascular indication.

Lovenox, said by R-PR to be the number one-selling low-molecular-weight heparin in the world, is also the only drug in its class in the USA indicated for the prevention of deep vein thrombosis in hip and knee replacement and abdominal surgery. It was cleared for marketing in the USA and Canada in 1993, and has been sold in Europe under the brand names Lovenox and Clexane since 1987.