Fennec Resubmits Pedmark NDA To FDA

By RTTNews Staff Writer ✉ | Published: 3/24/2022 7:29 AM ET

Fennec Pharmaceuticals Inc. (FENC) said on Thursday that it has resubmitted its New Drug Application for Pedmark to the FDA.

Pedmark is a formulation of sodium thiosulfate, proposed for the prevention of platinum-induced ototoxicity in pediatric patients, especially cancer patients who have undergone chemotherapy, from one month to below 18 years of age group with localized, non-metastatic, solid tumors.

Pedmark has already received Breakthrough Therapy and Fast Track Designation by the FDA in 2018.

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