W-L withdraws clinafloxacin NDA

Warner-Lambert has withdrawn the US New Drug Application for itsfluoroquinolone antibiotic clinafloxacin, which it originally predicted would be a key drug in its pipeline, over safety concerns raised about other drugs in the class. In June, the Food and Drug Administration heavily restricted the use of Pfizer's Trovan/Turvel (trovafloxacin/alatrofloxacin; Marketletter June 14). Then in November, Glaxo Wellcome withdrew its antibiotic Raxar (grepafloxacin) from the market following reports of seven deaths which may have been associated with the drug (Marketletter November 1).

Undeterred, however, SmithKline Beecham recently filed its first marketing application for a new once-daily product, called Factive (gemifloxacin), while Bayer has also recently gained US approval of its new quinolone antibiotic Avelox (moxifloxacin), which has also been launched in Germany (Marketletter December 20). Since the W-L drug was intended only for use in life-threatening infections, a spokesman said the company might ask for "compassionate-use" designation, allowing patients with few other choices to use it.