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Onivyde Approval History

  • FDA approved: Yes (First approved October 22nd, 2015)
  • Brand name: Onivyde
  • Generic name: irinotecan liposomal
  • Dosage form: Injection
  • Previous name: MM-398
  • Company: Merrimack Pharmaceuticals, Inc.
  • Treatment for: Pancreatic Cancer

Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan indicated for the treatment of post-gemcitabine metastatic adenocarcinoma of the pancreas.

Development History and FDA Approval Process for Onivyde

Oct 22, 2015Approval FDA Approves Onivyde (irinotecan liposome injection) for Advanced Pancreatic Cancer
Jun 25, 2015U.S. FDA Grants Priority Review for MM-398 New Drug Application
Apr 27, 2015Merrimack Pharmaceuticals and Baxter BioScience Announce Completion of NDA Submission for MM-398 as a Treatment for Post-Gemcitabine Metastatic Pancreatic Cancer

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