Heron Therapeutics receives FDA approval for CINVANTI sNDA

Heron Therapeutics announced that the FDA has approved Heron’s supplemental New Drug Application, or sNDA, for CINVANTI injectable emulsion, for intravenous use. The sNDA requested FDA approval to expand the administration of CINVANTI beyond the already approved administration method to include a 2-minute IV injection. CINVANTI is the first and only polysorbate 80-free, IV formulation of an NK1 receptor antagonist (RA) indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND(R) capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce CINV in both the acute phase and the delayed phase.

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