BioCentury
ARTICLE | Clinical News

Abstral fentanyl regulatory update

November 19, 2012 8:00 AM UTC

Kyowa submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for Abstral fentanyl 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, Aug. 30, 2010). ...