Endo International PLC's operating company Par Pharmaceutical received final approval from the U.S. FDA for its new drug application for ephedrine sulfate injection.
The drug is a parenterally administered pressor agent to address hypotension, which is low blood pressure, in surgical settings.
U.S. sales of ephedrine sulfate injection products were about $177 million for the 12 months ended Nov. 30, 2016, according to IMS Health data.
Par Pharmaceutical anticipates shipping of the product to begin in February.