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NDA submitted for once-daily ciprofloxacin HCl, ciprofloxacin.(new drug application)(Brief Article)
2002 APR 11 - (NewsRx.com & NewsRx.net) -- Bayer Corp., Pharmaceutical Division, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) to market Cipro (ciprofloxacin hydrochloride and ciprofloxacin) in a once-daily modified release tablet formulation.
This proposed new formulation of ciprofloxacin has been submitted for consideration by the FDA for the treatment of uncomplicated urinary tract infections (UTIs). The current tablet form of ciprofloxacin is approved for 250-mg dosing every 12 hours for 3 days for women with uncomplicated UTIs. The new ciprofloxacin hydrochloride and ciprofloxacin formulation has been submitted for once-daily dosing for three days.
"Bayer developed a once-daily formulation of ciprofloxacin for uncomplicated UTIs to offer a more convenient dosing alternative for patients and physicians," said Karen A. Dawes, senior vice president, Business Group Head, Pharma U.S.A, Bayer Corporation. "This NDA submission represents Bayer's commitment to developing and bringing to market ...
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Source: HighBeam Research, NDA submitted for once-daily ciprofloxacin HCl, ciprofloxacin.(new...