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.
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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