Posted by Michael Wonder on 02 Oct 2020
Lantheus submits new drug application to the U.S. FDA for PyL (18F DCFPyL), a PSMA targeted prostate cancer imaging agent
30 September 2020 - Sep. 30, 2020-- Lantheus today announced the submission of a new drug application to the U.S. FDA for PyL (18F DCFPyL), a prostate specific membrane antigen targeted positron emission tomography imaging agent for prostate cancer.
The new drug application includes a request for priority review, which if granted, could shorten the FDA’s review of the NDA to six months from the time of acceptance, versus the standard review timeline of 10 months from acceptance.
The Company expects to receive notification from the FDA confirming acceptance of the filing for substantive review in early December 2020.
