Orphan Drug Designation (ODD)
ODDSpecial status granted to drugs developed for rare diseases (affecting <200,000 people in US). Provides incentives including 7-year market exclusivity, tax credits, and reduced filing fees.
Ejemplos
- Imatinib for CML (initially orphan)
- Nusinersen for SMA
- Over 5,000 designated, ~800 approved
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Special status granted to drugs developed for rare diseases (affecting <200,000 people in US). Provides incentives including 7-year market exclusivity, tax credits, and reduced filing fees.