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Fennec Pharma expects a Complete Response Letter from the FDA for Pedmark.

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Published:30th Nov 2021
Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, announced that it expects to receive a Complete Response Letter (CRL) after the PDUFA target action date of November 27, 2021 from the FDA regarding its New Drug Application (NDA) for Pedmark (a unique formulation of sodium thiosulfate), for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients greater than 1 month to 18 years of age with localized, non-metastatic, solid tumors.

The FDA has indicated that, following a recent completion of a pre-approval inspection of the manufacturing facility of our drug product manufacturer, deficiencies have been identified. Once the official CRL is received, the Company plans to request a Type A meeting to discuss the deficiencies and steps required for the resubmission of the NDA for Pedmark.

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and is particularly harmful to the survivors of pediatric cancer.

Condition: Cisplatin-induced Hearing Loss
Type: drug

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