On October 8, 2020 Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee") reported that the 505(b)(2) New Drug Application (NDA) for FP-001 LMIS 50mg, or CAMCEVI 42MG, a ready-to-use 6-month depot formulation of leuprolide mesylate, has been accepted for review by the U.S. Food and Drug Administration (FDA) (Press release, Foresee Pharmaceuticals, OCT 8, 2020, View Source [SID1234568241]).

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In its Day-74 letter, the FDA stated that the New Drug Application (NDA) for CAMCEVI 42MG is sufficiently complete to permit a substantive review. The goal date under the Prescription Drug User Fee Act (PDUFA) is May 27, 2021.

"This marks another important regulatory milestone for the CAMCEVI franchise," said Dr. Ben Chien, Founder and Chairman of Foresee. "We are confident that if approved, with a strong commercial partnership in the US, CAMCEVI 42MG and the CAMCEVI franchise will provide patients, as well as healthcare providers, a safe and easy-to-use treatment option with its differentiated ready-to-use profile. We look forward to the successful launch of the CAMCEVI franchise."

The NDA submission for CAMCEVI 42MG is supported by a previously communicated successful Phase 3 clinical study in 137 Advanced Prostate Carcinoma patients, where treatment with CAMCEVI 42MG injection every 6 months was demonstrated to be effective, safe and well tolerated.