FDA Approves Ephedrine Sulfate Injection

The FDA approved an injectable for hypotension in surgical settings.

Endo International announced the US Food and Drug Administration (FDA) has given final approval to its New Drug Application for ephedrine sulfate injection. The drug is administered parenterrally as a pressor agent to address clinically important hypotension in surgery.

The most common adverse reactions are nausea, vomiting, and tachycardia.

The product is packaged for injections in single use vials, 1 mL per use, and comes in a carton of 25 50mg/ML.

An Endo operating company, Par Pharmaceutical expects to start shipping the product in February.

Precautions include the fact that there are pressor effects with concomitant use of oxytocic drugs and that repeated administration may cause tachyphylaxis.

According to the company, US sales of ephedrine sulfate injection products were about $177 million for the 12 months ending Nov. 30, 2016.