Evdi (trabectedin)
New formulation or manufacturer
- Region
- 🇺🇸 US
- Active substance
- trabectedin
- Company
- Apotex
- Status
- Approved
- FDA approval
- Fri 01 May 2026
- Designations
- New formulation or manufacturer
- Application
- NDA220837
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Fri 01 May 2026🇺🇸 FDA approval
FDA approves Evdi (trabectedin): new formulation or manufacturer
Apotex; NDA220837; New formulation or manufacturer; solution · source
Same substance in other markets
- 🇪🇺 Yondelis Authorised · Pharma Mar S.A.
- 🇺🇸 Trabectedin Approved · Ever
- 🇪🇺 Trabectedin Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Yondelis Refused · Pharma Mar S.A.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.