Fennec Pharma Initiates Rolling NDA For PEDMARKTM - Quick Facts

(RTTNews) - Fennec Pharmaceuticals Inc. (FENC, FRX.TO), following a pre-submission meeting with the oncology division of the FDA, has initiated a rolling New Drug Application for PEDMARKTM for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localized, non-metastatic, solid tumors.

The company said it is targeting U.S. approval of PEDMARKTM in the second half of 2019. PEDMARKTM has been granted Orphan Drug, Breakthrough Therapy and Fast Track designations from the FDA.

In Europe, Fennec intends to submit its Marketing Authorisation Application via the European Medicines Agency's Paediatric-use marketing authorisation (PUMA) pathway next year.