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Onivyde FDA Approval History

FDA Approved: Yes (First approved October 22, 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 Timeline 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

Further information

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