FDA approves expanded indication for Cinvanti

27 February 2019

The US Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Cinvanti (aprepitant) injectable emulsion, for intravenous (IV) use.

The sNDA from US biotech Heron Therapeutics (Nasdaq: HRTX) requested FDA approval to expand the administration of Cinvanti beyond the already approved administration method to include a 2-minute IV injection. The original route of administration was a 30-minute IV infusion.

Heron’s shares gained 3.5% to $28.80 in after-hours trading yesterday following the announcement.

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