Kyowa submits Japanese NDA for Abstral

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for Abstral fentanyl ( KW-2246) to treat breakthrough cancer pain. The application includes additional clinical data requested by Japan's Pharmaceuticals and Medical Devices Agency in 2010. Kyowa withdrew an NDA for the sublingual mucoadhesive fentanyl that year following the request (see BioCentury Extra, Aug. 27, 2010). ...