ARTICLE | Clinical News

Abstral fentanyl regulatory update

September 13, 2010 7:00 AM UTC

ProStrakan reported that FDA said it will not meet the expected PDUFA date in early September for an NDA for Abstral fentanyl to treat breakthrough cancer pain. ProStrakan said the delay was due to ongoing discussions with the agency regarding the REMS for Abstral. FDA previously extended the original PDUFA date of June 4 by 3 months after ProStrakan submitted additional information on its proposed REMS at the agency's request. Orexo granted ProStrakan rights to the sublingual mucoadhesive fentanyl in the U.S. and Europe, Paladin rights in Canada and Kyowa rights in Japan. Abstral is already marketed in Europe. ...