Fennec Pharma: FDA Issues CRL Due To Manufacturing Deficiencies - Quick Facts

Fennec Pharmaceuticals Inc. (FENC) has received a Complete Response Letter from FDA regarding the company's New Drug Application for PEDMARK. The CRL was issued as a result of identified manufacturing deficiencies. Fennec plans to request a Type A meeting with the FDA.

Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, said: "We will work closely with our current manufacturer as well as the FDA to fully address the issues raised in the letter. In addition, we continue to advance our second drug product manufacturing facility."

Fennec Pharmaceuticals is a specialty pharmaceutical company focused on the development of PEDMARK for the prevention of platinum-induced ototoxicity in pediatric patients.

Shares of Fennec Pharmaceuticals were down 3% in pre-market trade on Tuesday.

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