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Fennec Pharma Resubmits NDA For Pedmark

Fennec Pharmaceuticals Inc. (FENC) has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Pedmark for the prevention of ototoxicity induced by cisplatin chemotherapy in pediatric patients with localized, non-metastatic, solid tumors.

The re submission for Pedmark follows the complete response letter it had received from the FDA in August 2020, pointing out deficiencies with the manufacturing facility of the drug.

The FDA had not sought any further clinical data as there was no clinical safety or efficacy issues.

"If approved, PEDMARK stands to be the first FDA approved therapy to reduce the risk of cisplatin induced ototoxicity in pediatric patients," said Rosty Raykov, Chief Executive Officer of Fennec Pharmaceuticals, Inc.

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