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BioWorld - Wednesday, May 14, 2025
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Home » Fennec finally finds FDA approval for Pedmark
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Fennec finally finds FDA approval for Pedmark

Sep. 21, 2022
By Lee Landenberger
It took resolving issues from two complete response letters for Fennec Pharmaceuticals Inc. to finally land U.S. FDA approval of Pedmark. The injectable formulation of sodium thiosulfate is for reducing the risk of platinum-induced ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors. Approval of the NDA arrived Sept. 20, three days before its Sept. 23 PDUFA date.
BioWorld Regulatory Cancer Ocular U.S. FDA

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