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Akynzeo FDA Approval History

FDA Approved: Yes (First approved October 10, 2014)
Brand name: Akynzeo
Generic name: netupitant and palonosetron
Dosage form: Capsules
Company: Helsinn Healthcare SA
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Akynzeo (netupitant and palonosetron) is a substance P/neurokinin 1 (NK1) receptor antagonist and serotonin-3 (5-HT3) receptor antagonist fixed-dose combination indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Development timeline for Akynzeo

Oct 10, 2014Approval FDA Approves Akynzeo (netupitant and palonosetron) for Chemotherapy-Induced Nausea and Vomiting
Jan 12, 2011FDA Agrees to Special Protocol Assessment (SPA) to Evaluate the Safety and Efficacy of a Fixed-Dose Combination (FDC) of Netupitant and Palonosetron in the Prevention of CINV

Further information

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