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Executive Summary

Bristol-Myers Squibb's Cefzil (cefprozil) will be available on pharmacy shelves by February and detailing to physicians will begin "immediately," the company said following FDA approval of the oral cephalosporin antibiotic on Dec. 23. FDA review of the Cefzil NDA took one year and nine months; Bristol-Myers Squibb submitted the NDA (number 50-664) on March 30, 1990. FDA gave the product a "1C" rating, signifying a new molecular entity representing little or no gain over existing therapies. The name Cefzil is a change from the brand name (Procef) Bristol-Myers used during cefprozil's development. Bristol-Myers Squibb did not disclose pricing information. Promotion for the drug will be handled by the New York advertising agency R. A. Becker. Developed by Bristol-Myers, Cefzil joins a broad and deep Bristol-Myers Squibb anti-infective product line and provides a successor to the company's first generation oral cephalosporin Duracef (cefadroxil), which has avoided generic competition in the patent courts due to a still-valid process patent. Cefzil is indicated for "mild to moderate infections," FDA approved labeling notes, for the following conditions: "pharyngitis/tonsillitis caused by Streptococcus pyogenes; otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis; secondary bacterial infection of acute bronchitis and acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta lactamase positive and negative strains) and Moraxella (Branhamella) catarrhalis; and uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes." The Cefzil approval covers two tablet dosage forms -- 250 mg and 500 mg -- as well as two liquid suspension dosage forms -- 125 mg/5 ml and 250 mg/5 ml. The recommended adult dosage for treating upper respiratory tract infections is 500 mg once a day for 10 days, while the recommended dosage regimen for lower respiratory infections is 500 mg twice a day for 10 days. Bristol-Myers said that Cefzil's once- and twice-a-day dosing "may enhance patient compliance" over other antimicrobial agents. Eli Lilly's Ceclor (cefaclor), the best-selling cephalosporin antibiotic with $500 mil. in U.S. sales in 1990, is usually given in 250 mg doses three times a day, as is SmithKline Beecham's Augmentin (amoxicillin/clavulanate), while Glaxo's Ceftin (cefuroxime axetil) is taken twice a day and Lederle's Suprax (cefixime) is taken once or twice daily. Cefzil labeling includes an efficacy comparison from controlled clinical trials versus Augmentin for the treatment of otitis media due to Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. Cefzil achieved eradication rates of 83%, 56%, and 71% against the three pathogens, respectively. The rates for amoxicillan were 78%, 73%, and 83%. In a much smaller group of patients (seven), both drugs were 100% effective in eradicating Streptococcus pyogenes. Cefzil showed a bacterial eradication rate of 72% (112 out of 155 patients) while Augmentin was effective in 77% (136 out of 176 patients). However, labeling notes that "adverse reactions, primarily diarrhea and diaper rash, were reported two times more frequently" in the Augmentin group -- 21% with Cefzil versus 41% with Augmentin in children 6 months to two years of age; and 10% with Cefzil versus 19% with Augmentin in children three to 12 years of age. The labeling's adverse reaction data from over 8,000 patients worldwide states that "approximately 2% of patients discontinued cefprozil therapy due to adverse events." The most common adverse events were gastrointestinal, including diarrhea, nausea, vomiting, and abdominal pain. FDA's approval letter for Cefzil requires Bristol-Myers to perform "a study of food effect on absorption of cefprozil tablets within six months" and dissolution tests on the tablets.

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