Posted by Michael Wonder on 07 Oct 2019
Pfenex receives U.S. FDA approval for PF708 to treat osteoporosis
7 October 2019 - Comparative human factors study report expected to be submitted to FDA as early as the second half of October 2019.
Pfenex announced today that the U.S. FDA has approved the new drug application for PF708 submitted under the 505(b)(2) regulatory pathway, with Forteo (teriparatide injection) as the reference drug.
Like Forteo, the FDA approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk for fracture.
