Drug major Lupin on Monday said its Japanese subsidiary Kyowa Pharmaceutical has entered into an agreement with Astellas Pharma for exclusive right to distribute and promote extended-release tablets of quetiapine fumarate in Japan.
In a BSE filing, Lupin said: “Astellas submitted a new drug application (NDA) with the ministry of health, labour and welfare in Japan for extended-release tablets of quetiapine fumarate for the indication of improvement of depressive symptoms associated with bipolar disorder”.
“When Astellas obtains an approval for the new drug application of extended-release tablets of quetiapine fumarate, based on the agreement, Kyowa will exclusively distribute and promote the products in Japan,” it added.