Bayer denies drug promotion for unlabeled medicine in China
Bayer Healthcare Tuesday said that it forbids any form of promotion of drugs for unlabeled medical indications in the company, after a doctor in Shanghai accused that one of its anticoagulant medicines is being used for an indication for which the drug is not authorized in China, Global Times reported.
Xarelto (rivaroxaban), a medicine produced by Bayer, is used for reducing the risk of venous thromboembolism (blood clotting) in people who undergo knee or hip replacement surgery, which is the only approved use of the medicine in China.
But a vascular doctor from a Shanghai-based hospital accused earlier this month that Xarelto has been used for treating deep vein thrombosis (DVT) in some hospitals in China, but the indication is not approved yet in China.
However, Bayer's Xarelto is authorized for DVT treatment in 46 countries and regions so far, including the European Union, and the company said it has also submitted Xarelto to China's State Food and Drug Administration (SFDA) at the end of 2011, in order to seek approval for treating DVT indication in China, the newspaper reported.