www.fdanews.com/articles/211352-fda-approves-nexus-emerphed-pre-filled-syringes
FDA Approves Nexus’ Emerphed Pre-Filled Syringes
March 3, 2023
The FDA has approved Nexus Pharmaceuticals’ Emerphed (ephedrine sulfate injection) in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes to treat hypotension during anesthesia.
The device is the first 10 mL ephedrine sulfate injection pre-filled syringe to be approved by the agency.
Nexus first received FDA’s approval for Emerphed injection in a ready-to-use vial in April 2020 and gained a patent covering certain applications of the ready-to-use injection in August 2021.
The approved product is available immediately in the U.S. in cartons of ten syringes.