US Food and Drug Administration (FDA) has given approval to Nexus Pharmaceuticals for its Emerphed (ephedrine sulfate injection) in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes.
The company claimed that its 10mL presentation is the only FDA-approved ready-to-administer 10mL pre-filled syringe available.
Nexus Pharmaceuticals CEO and president Usman Ahmed said: “We are pleased to announce the addition of our latest Emerphed product to our suite of existing FDA-approved, ready-to-use ephedrine sulfate products.
“These patented products showcase Nexus’ ability to provide innovative therapies that address clinicians’ concerns about delivering efficient and safe medications. With Emerphed, we look forward to transforming how patients are treated, while continuing to offer the quality they’ve come to expect.”
In April 2020, the company got FDA approval for Emerphed (ephedrine sulfate) injection in a ready-to-use vial.
In August 2021, a patent encompassing some applications of Emerphed ready-to-use ephedrine sulfate injection was issued by the US Patent and Trademark Office (USPTO).
Since then, Nexus has received many further patents on its Emerphed line of vials and syringes and continues to seek more patent protection related to Emerphed.
An alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent, Emerphed (ephedrine sulfate injection) is indicated to treat clinically important hypotension occurring in the setting of anesthesia.
Nexus Pharmaceuticals chief operating office Omair Ahmed said: “In 2020, we were the first manufacturer to launch an FDA-approved ephedrine sulfate injection in a ready-to-use vial. Since that time, the market has changed and refined itself, so we are incredibly excited to introduce the next generation of ready-to-administer ephedrine sulfate products once again.”
Nexus Pharmaceuticals’ Emerphed pre-filled syringe is available in cartons of ten single-dose syringes.