FDA Approves Emerphed (ephedrine sulfate) Ready-to-Use Injection for Hypotension During Anesthesia
Lincolnshire, Ill., April 21, 2020 — Nexus Pharmaceuticals announced today it has received U.S. Food and Drug Administration (FDA) approval for its patent-pending New Drug Application (NDA) Emerphed, the first and only premixed ephedrine in a ready-to-use 50 mg/10 mL vial. With no need for compounding, diluting, or mixing, Emerphed saves valuable staff time while also reducing the potential for preparation error and waste.
“With the approval of our Emerphed Injection, Nexus Pharmaceuticals is looking to streamline the standard of care in the operating room,” said Mariam S. Darsot, Chief Executive Officer of Nexus Pharmaceuticals.
Shahid Ahmed, Chief Scientific Officer added, “By offering a premixed, ready-to-use formulation of ephedrine, we are helping to reduce precious time spent preparing drugs in the OR, as well as reducing waste and minimizing the potential for human error.”
Emerphed will be available in a ready-to-use 10 mL vial that does not require further dilution. Each vial contains 50 mg ephedrine sulfate in 0.9% sodium chloride.
INDICATIONS AND USAGE
Ephedrine Sulfate injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
WARNINGS AND PRECAUTIONS
Emerphed can cause pressor effects with concomitant use with oxytocic drugs. Can also cause tachyphylaxis with repeated administration of ephedrine.
Overdose of Emerphed can cause a rapid rise in blood pressure. In the case of an overdose, careful monitoring of blood pressure is recommended. If blood pressure continues to rise to an unacceptable level, parenteral antihypertensive agents can be administered at the discretion of the clinician.
Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. To report SUSPECTED ADVERSE REACTIONS, contact Nexus Pharmaceuticals at (855) 642-2594 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For full prescribing information, please see the following link.
About Nexus Pharmaceuticals, Inc.
Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus Pharmaceuticals ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable, lifesaving treatment options when and where they’re needed most.
Source: Nexus Pharmaceuticals, Inc.
Posted: April 2020