Posted by Michael Wonder on 28 Jul 2020
Foresee Pharmaceuticals announces submission of NDA for FDA approval of LMIS 50 mg
27 July 2020 - Foresee Pharmaceuticals announced today that it has submitted to the U.S. FDA a new drug application for Camcevi 42mg (FP-001 LMIS 50 mg), a ready-to-use 6-month depot formulation of leuprolide mesylate.
The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer.
This submission is supported by a previously communicated successful Phase 3 study in 137 advanced prostate carcinoma patients, where treatment with LMIS 50 mg injection every 6 months was demonstrated to be effective, safe and well tolerated.
