Fennec Pharmaceuticals (NASDAQ:FENC) has completed
its rolling submission of a New Drug Application (NDA) to the FDA for
PEDMARK (a unique formulation of sodium thiosulfate) for intravenous
use.
The company has also submitted a marketing
application to the European Medicines Agency for sodium thiosulfate
(tradename to be determined).
The PEDMARK indication is 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 FDA has a 60-day review period to determine if
NDA is acceptable for filing. If granted a priority review, the PDUFA
action date is expected in Q3.
https://seekingalpha.com/news/3540386-fennec-pharma-completes-nda-submission-for-pedmark
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