Fennec Gets Official Notice of FDA Rejection of Pedmark
November 30 2021 - 6:50AM
Dow Jones News
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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