Posted by Michael Wonder on 19 Feb 2019
Pfenex announces FDA acceptance of NDA for PF708
19 February 2019 - FDA sets PDUFA date of 7 October 2019.
Pfenex today announced that the U.S. FDA has accepted for review the 505(b)(2) new drug application for the Company’s lead product candidate, PF708, a Forteo therapeutic equivalent in the treatment of osteoporosis, which achieved $1.6 billion in global product sales in 2018. The acceptance of the application indicates the application is sufficiently complete to permit a substantive review by the FDA.
The FDA set a target goal date under the Prescription Drug User Fee Act of 7 October 2019. Additionally, the Day-74 letter did not indicate that FDA is planning to hold an advisory committee meeting to discuss the application.
