Endo Announces U.S. FDA Approval of Ephedrine Sulfate Injection, USP

Endo International plc announced that one of its operating companies, Par Pharmaceutical has received final approval from the U.S. Food and Drug Administration for its New Drug Application for ephedrine sulfate injection, a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings. According to IMS Health data, U.S. sales of ephedrine sulfate injection products were approximately $177 million for the 12 months ended November 30, 2016.

Ephedrine sulfate for injection is packaged in cartons of twenty-five 50mg/mL, 1mL single use vials.  Par expects to start shipping the product in February 2017.