Posted by Michael Wonder on 14 Jan 2020
Chiasma announces FDA acceptance of Mycapssa new drug application resubmission
13 January 2020 - FDA sets PDUFA date of 26 June 2020.
Chiasma today announced that the U.S. FDA accepted for review the new drug application resubmission for its oral octreotide capsules investigational product candidate, conditionally trade named Mycapssa.
Chiasma is developing Mycapssa for the maintenance treatment of adults with acromegaly.
The FDA assigned a Prescription Drug User-Fee Act target action date of 26 June 2020, which is a six month review.
