Rivaroxaban (Xarelto) Gains First FDA Approval for DVT Prevention
Rivaroxaban(Xarelto, Janssen) received FDA approval today for the prevention of deep vein thrombosis which may lead to a pulmonary embolism in patients undergoing knee or hip replacement surgery. The drug is a once-daily oral anticoagulant and has been approved for use at a 10 mg dose, once-daily for 35 days following hip replacement and for 12 days following knee replacement surgery.The company ...

U.S. Firm Offering Free FDA Regulatory Training Sessions in China? It s a Win/Win
Last week FDAImports.com and ExportToUsa.com.cn hosted a series of free FDA regulatory training sessions in Beijing and Shanghai, China for Chinese companies exporting FDA-regulated goods to the United States. Over 70 people attended the training sessions from over 30 companies including companies on FDA import alert, companies seeking first-time access to the U.S. market, and companies with a ...