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Cinvanti FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Oct 29, 2019.

FDA Approved: Yes (First approved November 9, 2017)
Brand name: Cinvanti
Generic name: aprepitant
Dosage form: Injection
Company: Heron Therapeutics, Inc.
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Cinvanti (aprepitant) is a polysorbate 80 free, intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Cinvanti is indicated in adults, in combination with other antiemetic agents, for the prevention of:

  • acute and delayed nausea and vomiting associated with initial and repeat courses of HEC (highly emetogenic cancer chemotherapy) including highdose cisplatin as a single-dose regimen.
  • delayed nausea and vomiting associated with initial and repeat courses of MEC (moderately emetogenic cancer chemotherapy) as a single-dose regimen.
  • nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.

Development Timeline for Cinvanti

DateArticle
Oct 22, 2019Approval FDA Approves Supplemental New Drug Application to Expand Cinvanti (aprepitant) Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)
Feb 26, 2019Approval FDA Approves Supplemental New Drug Application to Expand Cinvanti (aprepitant) Label for IV Push
Nov  9, 2017Approval FDA Approves Cinvanti (aprepitant) Injectable Emulsion for the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting (CINV)
Jan 16, 2017Heron Announces Submission of Cinvanti NDA for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)

Further information

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