FDA Confirms Paragraph IV Patent Litigation for Aprepitant Intravenous Emulsion
Heron Therapeutics has two drugs on the market to prevent the nausea and vomiting associated with chemotherapy. Now, it has one to prevent the sickness that often comes after surgery.
FDA Confirms Paragraph IV Patent Litigation for Aprepitant, Azilsartan, Bupivacaine, Cladribine, Elrombopag, Fosnetupitant, Fostamatinib, Ivacaftor and Sodium Thiosulfate.
FDA Confirms Paragraph IV Patent Litigation for Aprepitant
SAN DIEGO, Nov. 18, 2021 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-019 (aprepitant) injectable emulsion for the prevention of postoperative nausea and vomiting (PONV) in adults. HTX-019 is a proprietary intravenous (IV) formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist (RA) that is approved for PONV prevention.
Torrent Pharms Generic Aprepitant Receives Approval in US
SAN DIEGO, July 16, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced the initiation of the GUARDS-1 Study, a Phase 2 clinical study evaluating CINVANTI (aprepitant) injectable emulsion in early hospitalized patients with Coronavirus Disease 2019 (COVID-19). The study initiation follows clearance from the U.S. Food and Drug Administration (FDA) of Heron's Investigational New Drug application for CINVANTI for the treatment of COVID-19.
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has approved Heron's supplemental New Drug Application (sNDA) for CINVANTI (aprepitant) injectable emulsion, for intravenous (IV) use. The sNDA requested FDA approval to expand the administration of CINVANTI beyond the already approved administration method (a 30-minute IV infusion) to include a 2-minute IV injection.
Enforcement Report - Week of December 26, 2018