Posted by Michael Wonder on 03 Oct 2017
Sucampo Pharmaceuticals announces FDA acceptance of sNDA for Amitiza in children with paediatric functional constipation, with priority review designation
28 September 2017 - Sucampo Pharmaceuticals today announced that the U.S. FDA has accepted for filing its recently submitted supplemental new drug application for lubiprostone (Amitiza) in children aged 6 to 17 years with paediatric functional constipation.
The filing has received priority review designation from the FDA.
Priority review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. The granting of priority review status accelerates the timing of the FDA review of the application. The FDA has assigned a user fee goal date of 28 January 2018.
