Hikma’s Phenylephrine is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia. This NDA has been approved under Section 505(b)(2) of the US Federal Food Drug and Cosmetic Act and it is the only FDA-approved version of Phenylephrine HCl Injection, USP.

Said Darwazah, CEO of Hikma, said, “This approval demonstrates our strong regulatory capabilities and the successful execution of our strategy to develop a more differentiated injectable product portfolio."

According to IMS Health, sales of Phenylephrine Injection in the US market were approximately $14 million for the 12 months ending November 2012.