MediciNova, Inc., a
biopharmaceutical company that is publicly traded on the NASDAQ Global Market
MNOV and the Jasdaq Market of the Osaka Securities Exchange (Code
Number: 4875), today announced that it has received Fast Track designation
from the U.S. Food and Drug Administration (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.
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