Pharma Focus Europe

Nexus Pharmaceuticals, Inc. Receives FDA Approval for Their Pre-Filled Syringe of EMERPHED® (ephedrine sulfate injection)

Tuesday, July 25, 2023

Nexus Pharmaceuticals, Inc. has recently received approval from the US Food and Drug Administration (FDA) for its latest product, EMERPHED® (ephedrine sulfate injection), which comes in two variants of pre-filled syringes - 25mg/5mL and 50mg/10mL. Notably, the 50mg/10mL presentation marks the first and only FDA-approved ready-to-administer 10mL pre-filled syringe currently available in the market.

Usman Ahmed, the Chief Executive Officer and President of Nexus, expressed his satisfaction with the new addition to their FDA-approved suite of ephedrine sulfate products. He emphasized Nexus' commitment to delivering innovative therapies that address the concerns of healthcare professionals regarding safe and efficient medication administration. With the introduction of EMERPHED®, the company aims to redefine patient treatment while maintaining the exceptional quality they are known for.

EMERPHED® initially received FDA approval in April 2020 for its ready-to-use vial presentation. Subsequently, the United States Patent and Trademark Office (USPTO) granted a patent in August 2021, covering certain applications of EMERPHED® Ready-to-Use Ephedrine Sulfate Injection. Nexus has since secured several additional patents for various EMERPHED® vial and syringe products and continues its efforts to pursue further patent protection related to EMERPHED®.

In February 2021, the Medical College of Wisconsin conducted a clinical study highlighting the advantages of using EMERPHED® (ephedrine sulfate injection) in a ready-to-use vial over traditional concentrated ephedrine. The study demonstrated reduced potential for errors and ease of use. MCW published a press release in February 2021, and the study was later featured in the Journal of Pharmaceutical Science and Technology in June 2021.

Omair Ahmed, the Chief Operating Officer of Nexus, stated that their company was the first to introduce an FDA-approved ephedrine sulfate injection in a ready-to-use vial back in 2020. Now, with the dynamic changes in the market, Nexus is excited to launch the next generation of ready-to-administer ephedrine sulfate products.
Nexus Pharmaceuticals' EMERPHED® pre-filled syringes, containing ten single-dose syringes, are immediately available for use.

EMERPHED® (ephedrine sulfate injection) functions as an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent, specifically indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.


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