FDA says SB's Factive is non-approvable

SmithKline Beecham suffered another blow to its new product roll-outwith the announcement that the US Food and Drug Administration has issued a non-approvable letter for its new quinolone antibiotic Factive (gemifloxacin mesylate), which was under review for the treatment of respiratory tract infections. Only days earlier, SB said it was suspending its clinical investigation on a potential cardiovascular drug, lotrafiban (Marketletter December 18, 2000), and last year also saw the company drop its potential breast cancer and osteoporosis drug idoxifene.

SB continues to believe in the drug

David Stout, SB's president of pharmaceuticals in North America, said "we are disappointed about the FDA's decision, however, we continue to believe that Factive will be an important contribution to current treatments and will enhance our anti-infective franchise." The company stresses that it plans to work closely with the agency to address issues raised in the non-approvable letter, which could involve additional steps ranging from further discussions of the clinical data to the initiation of additional trials.