Daiichi Sankyo receives approval for additional indication of anticancer agent Topotecin® injection
Posted: 23 December 2013 | | No comments yet
Daiichi Sankyo Company has received supplemental new drug application (sNDA) approval for Topotecin® injection 40 mg and 100 mg (irinotecan hydrochloride hydrate) for unresectable pancreatic cancer.
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today it received supplemental new drug application (sNDA) approval from Japan’s Ministry of Health, Labor and Welfare (hereafter MHLW) for Topotecin® injection 40 mg and 100 mg (irinotecan hydrochloride hydrate) for unresectable pancreatic cancer.
Topotecin® injection was developed at the request of the MHLW based on recommendation from the Review Committee for unapproved or off-label use of drugs with high medical needs conducted on March 23, 2012. Daiichi Sankyo submitted the sNDA for this indication in May 2013.
As a part of its CSR effort, Daiichi Sankyo is committed to making unapproved or off-label use of drugs with high medical needs available to patients who are waiting for them to be approved.
1 A MHLW working group that aims to accelerate the development process for drugs not yet approved in Japan but which are available in Europe and the U.S
