Pfizer announces approval of antibiotic
The U.S. Food and Drug Administration recently gave marketing clearance to New York City-based Pfizer’s Trovan (trovafloxacin) for the treatment of 14 bacterial infections, the largest number of indications ever included at an initial drug approval in the United States.
More than 13,000 patients participated in 87 studies involving Trovan and 30 comparative drug regimens, the largest clinical trial program in Pfizer history.
A member of the quinolone class of antibiotics, Trovan is effective against four bacterial groups: gram-negative, gram-positive, atypical, and anaerobic bacteria. The drug is available in both oral and intravenous formulations and can be administered with a once-a-day dosing. Common side effects are dizziness, nausea, headache, and lightheadedness.
The drug became available by prescription in February and has been approved for use in adults with the acute bacterial exacerbations of chronic bronchitis, acute sinusitis, community-acquired pneumonia, nosocomial (hospital-acquired) pneumonia, complicated intra-abdominal infections, gynecologic and pelvic infections, uncomplicated urinary tract infections, chronic bacterial prostatis, pelvic inflammatory disease, chlamydial cervicitis, gonorrhea, uncomplicated skin and skin structure infections, complicated skin and skin structure infections including diabetic foot and surgical prophylaxis. Trovan is the first antibiotic ever approved for oral prophylactic use in surgery.
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