Osaka, Japan –September 21, 2018 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approvals from the Ministry of Health, Labour and Welfare (MHLW) for public knowledge-based applications1 for the anti-cancer agent, OXALIPLATIN I.V. Infusion Solution 50 mg [SAWAI] / 100 mg [SAWAI] / 200 mg [SAWAI]) (brand products ELPLAT® I.V. Infusion Solution 50 mg / 100 mg / 200 mg) for the additional indication of small intestinal cancer.
With this approval, the products can now be prescribed and covered by insurance for the additional indication of OXALIPLATIN I.V. Infusion Solution.
By continuing to actively work on approvals for unapproved drugs and for the indications where gaps exist with branded equivalents, Sawai will further contribute to improving medical care in Japan and to meeting the diverse needs of patients.
- “Public Knowledge-Based Application” is a marketing authorization application that seeks supplemental indication approval for an existing drug. In this system, an application is submitted based on medical and pharmacological public knowledge of a drug’s safety and efficacy and does not require additional clinical studies to be conducted, in whole or in part.