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Fennec Prepared For Market As Pedmark Finally Gets FDA Nod

 
• By Alaric DeArment

After successive CRLs in 2020 and 2021, the drug gained a broad label for hearing loss in children treated with cisplatin for localized, non-metastatic solid tumors.

Fennec received FDA approval for Pedmark in children with cisplatin-associated hearing loss • Source: Shutterstock

After a long and arduous trek, Fennec Pharmaceuticals Inc. has received US Food and Drug Administration approval with a broad label for Pedmark (sodium thiosulfate) for treating hearing loss associated with the chemotherapy drug cisplatin in children. Now, the focus moves to commercialization of the drug.

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