SmithKline Beecham, one of the world's leading healthcare companies, announced that the U.S. Food and Drug Administration (FDA) issued a non-approval letter for Factive (gemifloxacin mesylate), an antibiotic under review for the treatment of respiratory tract infections.
The company plans to work closely with the FDA to address issues raised in the non-approval letter, which could involve additional steps ranging from further discussions of the clinical data to the initiation of additional trials.
"We are disappointed about the FDA's decision," said David Stout, president of Pharmaceuticals in North America for SmithKline Beecham. "However, we continue to believe Factive will be an important contribution to current treatments and will enhance our anti-infective franchise."