Fennec initiates rolling NDA in the US for Pedmark

Fennec Pharmaceuticals has initiated a rolling New Drug Application for Pedmark, a formulation for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to less than 18 years of age with localized, non-metastatic, solid tumors, following a pre-submission meeting with the oncology division of the FDA. The company is targeting U.S. approval of Pedmark in 2H19. Pedmark 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 pathway next year.
https://thefly.com/landingPageNews.php?id=2839701