Daiichi Sankyo Company has filed a supplemental new drug application for extended indication of anticancer agent Topotecin intravenous drip infusion 40mg, 100mg with the Japan's Ministry of Health, Labor and Welfare.
Topotecin intravenous drip infusion (irinotecan hydrochloride hydrate) is indicated for treatment of pancreatic cancer.
Following discussions by the Review Committee for Unapproved or Off-label Use of Drugs with High Medical Needs, the Japanese regulatory body requested the company to develop Topotecin intravenous drip infusion.
Research-based pharmaceutical company Daiichi Sankyo is focused on promoting unapproved or off-label use of drugs with high medical needs to patients in need of them.
Source:
http://drugdelivery.pharmaceutical-business-review.com/news/daiichi-seeks-approval-for-extended-indication-of-topotecin-in-japan-030613
