New Drugs Approved in 2020
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
Nausea
Postop Nausea, Vomiting Therapy Barhemsys Launched
Barhemsys is a selective dopamine-2 and dopamine-3 receptor antagonist.
Akynzeo Injection, a New Liquid Formulation, Now Available
Akynzeo is a combination of palonosetron, a 5-HT3 receptor antagonist, and fosnetupitant, a substance P/NK1 receptor antagonist.
Ready-to-Dilute Liquid Formulation of Akynzeo Injection Approved
The FDA has approved a new ready-to-dilute liquid formulation of Akynzeo® injection (fosnetupitant/palonosetron; Helsinn) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, in combination with dexamethasone in adults.
Chemotherapy-Induced Nausea and Vomiting Guidelines: Prophylaxis
The ASCO guideline provides updated recommendations for the prevention and management of chemotherapy-induced nausea and vomiting (CINV) based on the emetic risk of the treatment regimen.
Furosemide Plus Sodium Chloride Not Helpful in Treating SIAD
Adding furosemide with or without sodium chloride to fluid restriction is not more effective than fluid restriction alone at correcting hyponatremia in patients with the syndrome of inappropriate antidiuresis, a study found.
Barhemsys Approved for Postoperative Nausea and Vomiting
The FDA has approved Barhemsys (amisulpride; Acacia Pharma) for the prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class and for the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.
Cinvanti Single-Dose Regimen Approved for Patients Receiving Moderately Emetogenic Chemotherapy
Cinvanti injectable emulsion can be administered as a 2-minute intravenous injection or 30-minute intravenous infusion.
Microbial Growth Prompts Recall of Two Injectable Drugs
Heritage Pharmaceuticals has initiated a voluntary recall of Amikacin Sulfate Injection, USP, 1g/4mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL) after microbial growth was detected in 1 unreleased sublot of both products.
FDA Passes on Barhemsys NDA Again Due to Facility Issues
The FDA has issued a second complete response letter to Acacia Pharma regarding the New Drug Application for Barhemsys (amisulpride injection).
