Fennec Pharmaceuticals: FDA Accepts Pedmark Application's Resubmission
27 Avril 2022 - 01:01PM
Dow Jones News
By Colin Kellaher
Fennec Pharmaceuticals Inc. on Wednesday said the U.S. Food and
Drug Administration has accepted for filing its resubmitted
application seeking approval of Pedmark for the prevention of
hearing loss associated with cisplatin chemotherapy in
children.
The Durham, N.C., specialty pharmaceutical company said the
agency set a target action date of Sept. 23 for the
application.
The FDA in November rejected Fennec's application for Pedmark,
the company's lead drug candidate, for a second time due to issues
at the plant where the drug is made.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
April 27, 2022 06:46 ET (10:46 GMT)
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