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MERCK’s NOROXIN QUINOLONE GETS ADDED INDICATION FOR UNCOMPLICATED GONORRHEA

Executive Summary

Merck's broad-spectrum oral quinolone Noroxin (norfloxacin) gained an additional indication, the treatment of uncomplicated gonorrhea, on Nov. 26. Previously, Noroxin was approved for treatment of complicated and uncomplicated urinary tract infections. A new dosage regimen of Noroxin in treating uncomplicated urinary tract infections also received FDA clearance on Nov. 26. The new regimen calls for 400 mg every 12 hours for three days, while the previous dosing was 400 mg twice-daily for seven to 10 days. For uncomplicated urinary tract infections, a competitive quinolone, Miles' Cipro (ciprofloxacin) 250 mg tablets, is administered every 12 hours for a usual duration of seven to 14 days. Norwich Eaton's twice-daily nitrofurantoin product, Macrobid, was approved on Dec. 24 for the treatment of acute uncomplicated urinary tract infection. A 400-rep marketing unit is selling the follow-on to the four-a-day product Macrodantin. Roche received an additional indication for its broad-spectrum cephalosporin Rocephin (ceftriaxone sodium). On Dec. 9, the injectable antibiotic was approved for use in treating pharyngeal gonorrhea caused by nonpencillinase producing strains of Neisseria gonorrhoeae. Rocephin is also indicated for uncomplicated cervical and rectal gonorrhea, urinary tract infections, lower respiratory tract infections, as well as several other types of infections. This additional indication was Rocephin's second in 1991. The drug was also cleared by FDA as a once-a-day treatment for pediatric skin and skin structure infections. Rocephin is Roche's top product. The company touts Rocephin as "the No. 1 hospital antibiotic drug in the U.S. in all classes."

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