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FDA Approves Aprepitant Injection for CINV

Gina Columbus @ginacolumbusonc
Published: Thursday, Feb 28, 2019

Rudolph M. Navari, MD, PhD

Rudolph M. Navari, MD, PhD

The FDA has expanded the approval of aprepitant (Cinvanti) injectable emulsion to include a 2-minute intravenous (IV) use for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV).1

"We are pleased to have strengthened our CINV franchise with today's label expansion for Cinvanti, as we now have the only NK1 [receptor antagonist] that offers the benefits and flexibility of an IV push method of administration," said Barry Quart, PharmD, president and chief executive officer of Heron Therapeutics. "Administration of Cinvanti by 2-minute IV push is an important advantage for our customers compared to Emend IV, which requires reconstitution and an IV bag for infusion."

References

  1. Heron Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for IV Push. Heron Therapeutics. Published February 26, 2019. https://prn.to/2EDxtvR. Accessed February 28, 2019.
  2. Ottoboni T, Lauw M, Keller MR, Cravets M, Manhard K, Clendeninn N, Quart B. HTX-019 via 2-min injection or 30-min infusion in healthy subjects [published online ahead of print December 21, 2018]. Future Med. doi: 10.2217/fon-2018-0809.
  3. Heron Therapeutics Announces U.S. FDA Approval of CINVANTI (aprepitant) Injectable Emulsion for the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting (CINV). Heron Therapeutics. Published November 9, 2017. https://bit.ly/2NyINfA. Accessed February 28, 2019.
  4. Ottoboni T, Boccia G, Keller MR, Cravets M, Clendeninn N, Quart B. Bioequivalence of HTX-019 (aprepitant IV) and fosaprepitant in healthy subjects. Presented at: 2017 Hematology/Oncology Pharmacy Association Annual Conference; March 29-April 1, 2017; Anaheim, CA.

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