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FDA has granted Rare Pediatric Disease Designation to MediciNova’s MN-166 (ibudilast) for treatment of Type 1 - Early Infantile Krabbe disease

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Additional Information

Additional Relevant Details Under the FDA’s rare pediatric disease priority review voucher program, the sponsor may be eligible for a voucher that can be used to obtain a priority review for a subsequent human drug application. The FDA has previously granted orphan drug designation to MN-166 (ibudilast) for treatment of Krabbe disease.
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Catalyst Date
Occurred on:
Jan 18, 2016
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Related Keywords Fda, Rare Pediatric Disease Designation, Mn-166, Ibudilast, Type 1 - Early Infantile Krabbe Disease, Voucher, Priority Review, Human Drug Application