On October 24, the U.S. Food and Drug Administration (FDA) issued a news release announcing its approval of XOFLUZATM (baloxavir marboxil) for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
The FDA’s Commissioner, Scott Gottlieb, M.D., stated, “This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”
For additional information, access the FDA’s News Release: FDA approves new drug to treat influenza. For specific details regarding the approval of XOFLUZATM, access the FDA’s NDA Approval letter.
