MITIGARE™ is indicated for prophylaxis of gout flares in adults. This NDA has been approved under Section 505(b)(2) of the US Federal Food Drug and Cosmetic Act.

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

According to IMS Health, sales of colchicine in the US market were approximately $688 million for the 12 months ending August 2014.