Fennec Pharmaceuticals Expects FDA to Reject Pedmark Application Again
November 29 2021 - 6:55AM
Dow Jones News
By Colin Kellaher
Fennec Pharmaceuticals Inc. on Monday said it expects the U.S.
Food and Drug Administration will once again reject the company's
application for Pedmark due to issues at the plant where the drug
is made.
The Durham, N.C., specialty pharmaceutical company said it
expects to receive an FDA complete response letter, indicating that
the agency won't approve the application in its current form, now
that the Nov. 27 target action date for the application has
passed.
Fennec is seeking approval of Pedmark for intravenous
administration for the prevention of hearing loss associated with
cisplatin chemotherapy in children.
The FDA last year turned away Fennec's application after finding
deficiencies during a pre-approval inspection of the facility of
the company's drug-product manufacturer. Fennec resubmitted its
application earlier this year, and the FDA accepted it June with
the Nov. 27 target action date.
Fennec on Monday said the FDA has again found deficiencies at
its drug-product manufacturer> Once it receives official
rejection, Fennec will request a meeting with the agency to discuss
the steps needed to resubmit the Pedmark application, the company
said.
Shares of Fennec, which closed Friday at $9.64, fell 33% to
$6.44 in premarket trading Monday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 29, 2021 06:40 ET (11:40 GMT)
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