07.08.2018 12:18:10

Fennec Receives Positive Opinion On Pediatric Investigation Plan For PEDMARK

(RTTNews) - Fennec Pharmaceuticals Inc. (FENC, FRX.TO) announced that the Pediatric Committee of the European Medicines Agency has accepted the company's pediatric investigation plan for PEDMARK for the condition of the prevention of platinum-induced ototoxic hearing loss. The company was also advised that PEDMARKTM is eligible for submission of an application for a Pediatric Use Marketing Authorisation.

The decision allows Fennec to proceed with the submission of a Pediatric Use Marketing Authorisation in the European Union with incentives of automatic access to the centralized procedure and up to 10 years of data and market protection.

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