Ephedrine Sulfate Injection Receives FDA Nod

The FDA recently approved Endo International and Par Pharmaceutical’s new drug application for its 50 mg/ml ephedrine sulfate injection.

The FDA recently approved Endo International and Par Pharmaceutical’s new drug application for its 50 mg/ml ephedrine sulfate injection.

The drug, a parenterally administered pressor agent, is indicated for the treatment of clinically important hypotension in surgery.

Adverse events associated with the use of ephedrine sulfate include nausea, vomiting, and tachycardia. The FDA also warned that the concomitant use of the medication with oxytocic drugs could result in pressor effects, and that repeated administration could lead to tachyphylaxis.

Par Pharmaceuticals plans to launch its 50 mg/ml ephedrine sulfate injection as packaged cartons of 25 single-use vials in February 2017.