Posted by Michael Wonder on 01 Jan 2021
CytRx issues statement regarding U.S. regulatory review of arimoclomol for Niemann-Pick disease type C
31 December 2020 - CytRx today provided an update on the U.S. FDA review of Orphazyme new drug application for arimoclomol to treat Niemann-Pick disease type C.
According to Orphazyme, the FDA has extended the review period with a standard extension of three months in order to complete the review.
The updated Prescription Drug User Fee Act target action date is 17 June 2021.
