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Orphan Drug Designation (ODD)

ODD
Regulatory

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.

उदाहरण

  • Imatinib for CML (initially orphan)
  • Nusinersen for SMA
  • Over 5,000 designated, ~800 approved

क्या आप जानते हैं?

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.