ARTICLE | Clinical News
Shionogic gets Japanese approval for flu vaccine
March 2, 2018 6:40 PM UTC
Shionogi & Co. Ltd. (Tokyo:4507) said Japan's Ministry of Health, Labour and Welfare (MHLW) approved an NDA for Xofluza baloxavir marboxil (S-033188), the company's single-dose oral therapy to treat influenza types A and B. The company said it plans to launch the product immediately after it receives a National Health Insurance price listing.
Xofluza was designated for Japan's Sakigake accelerated approval pathway in 2015. Shionogi submitted an application to MHLW in October 2017 seeking the therapy's approval...