Posted by Michael Wonder on 22 Oct 2019
Heron announces FDA approval of supplemental new drug application to expand Cinvanti label for single-dose regimen for patients receiving moderately emetogenic chemotherapy
22 October 2019 - Heron Therapeutics today announced that the U.S. FDA has approved Heron's supplemental new drug application for Cinvanti (aprepitant) injectable emulsion for intravenous use.
The application requested FDA approval to expand the recommended dosage to include the 130 mg single-dose regimen for patients receiving moderately emetogenic chemotherapy.
Cinvanti is the first and only IV formulation of a substance P/neurokinin-1 receptor antagonist that is free of synthetic surfactants, including polysorbate 80, and that is approved for use as a 2-minute IV injection (also referred to as an IV push).
