Taxus in Japan
This article was originally published in The Gray Sheet
Boston Scientific launches Taxus Liberté paclitaxel-eluting stent after gaining reimbursement from Japan's National Health Insurance System March 2. Taxus Liberté was approved by the Ministry of Health, Labor and Welfare Jan. 28, and is the "only second-generation drug-eluting stent in Japan," according to Boston Scientific (1"The Gray Sheet" Feb. 2, 2009, p. 15). The firm has pointed to Liberté as an example of accelerating approval times in Japan, where the regulatory pathway has historically been difficult to navigate for device makers. Abbott filed for Japanese approval of the Xience V everolimus-eluting stent in June. Boston Sci also markets its first-generation Taxus Express2 stent in Japan. Liberté was introduced in the U.S. last fall (2"The Gray Sheet" July 28, 2008, p. 10)
You may also be interested in...
Boston Scientific CEO Jim Tobin says 2009 will be the year when his company's gamble on cardiac rhythm management begins to pay off the way it hoped when it entered the CRM business by buying Guidant in 2006
Boston Scientific plans to launch four new interventional cardiology products in 2008 after resolving a two-and-a-half-year-old company-wide FDA warning letter
FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.