By Chris Wack
Fennec Pharmaceuticals Inc. said the U.S. Food and Drug Administration has accepted for filing the resubmission of its new-drug application for Pedmark.
The specialty pharmaceutical company said Pedmark is intended to be used for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to 18 years of age with localized, non-metastatic, solid tumors.
The Prescription Drug User Fee Act target action date has been set for Nov. 27, 2021, the company said.
Fennec said that if approved, Pedmark stands to be the first FDA-approved therapy to reduce the risk of cisplatin-induced ototoxicity in pediatric patients.
Pedmark has been granted both fast-track designation and breakthrough-therapy designation by the FDA. The complete response letter received Aug. 10, 2020, referred to deficiencies with the facility of the drug product manufacturer; no clinical safety or efficacy issues were identified and there was no requirement for further clinical data, the company said.
Fennec Pharmaceuticals shares were up 23% to $8.15 in premarket trading.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires