By Colin Kellaher

 

Fennec Pharmaceuticals Inc. on Tuesday confirmed that the U.S. Food and Drug Administration has again rejected the company's application for Pedmark because of issues at the plant where the drug is made.

The Durham, N.C., specialty pharmaceutical company said the FDA issued a complete response letter identifying manufacturing deficiencies that need to be resolved before the agency can approve the application.

Fennec, which is seeking approval of Pedmark for the prevention of hearing loss associated with cisplatin chemotherapy in children, on Monday had warned that it expected the rejection, sending its shares down 50.4%.

The company said it plans to work closely with its current manufacturer and the FDA to address the issues raised in the letter, adding that it continues to advance its second drug-product manufacturing plant.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

November 30, 2021 06:35 ET (11:35 GMT)

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