First Approval Of Wyeth's LMWH Normiflo

American Home Products' Wyeth-Ayerst division has been granted approvalin the USA for Normiflo (ardeparin sodium), its low molecular weight heparin product, for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing knee replacement surgery. This is the first approval of the product worldwide, according to Wyeth.

Normiflo is the only LMWH available in the USA that is dosed based on a patient's weight, which makes administration easier as it eliminates the need for daily dosage adjustments and routine coagulation laboratory monitoring. All other drugs in the category are administered with a fixed dose.

"Weight-based dosing offers another choice in DVT prophylaxis, a choice that allows the surgeon to individualize the dose according to a patient's body weight to achieve a constant plasma level of anti-Xa activity," said assistant vice president for clinical affairs at Wyeth, Philip de Vane.