FDA grants fast track designation for MedicNova's MN-166 MediciNova and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), announced that it has received Fast Track designation from the U.S. FDA for MN-166 (ibudilast) for the treatment of methamphetamine dependence. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need. An important feature of the FDA's Fast Track program is that it emphasizes early and frequent communication between the FDA and the sponsor throughout the entire drug development and review process to improve the efficiency of product development. Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval.
MediciNova granted orphan status for idiopathic pulmonary fibrosis drug The FDA posted on its website that MediciNova has been granted orphan status for its treatment of idiopathic pulmonary fibrosis. Reference Link