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4/2/2004

Ketek Gets U.S. Marketing Approval

Kate Traynor

The Food and Drug Administration (FDA) on Thursday approved the marketing of telithromycin oral tablets, a new antimicrobial that targets disease-causing bacteria in the respiratory tract.

Aventis, which will market the product under the trade name Ketek, stated that the product is the first in its class—the ketolides—to receive marketing clearance in the United States. The FDA-approved labeling for telithromycin is not yet available.

Ketolides have been described in the medical literature as antibacterials structurally related to the macrolides.

According to the company, telithromycin is indicated, in adults, for the treatment of acute exacerbations of chronic bronchitis, acute bacterial sinusitis, and mild to moderate community-acquired pneumonia, including infections caused by multidrug-resistant Streptococcus pneumoniae.

An Aventis spokewsoman said that the product is formulated as 800-mg tablets that are taken once daily for 7–10 days to treat community-acquired pneumonia and for five days for the other indications. She said that Ketek will be available in late summer.

In a press release, the company described telithromycin as a targeted therapy specific for bacteria that infect the respiratory tract.

According to the company, the most common adverse events reported in clinical trials of telithromycin were nausea, headache, vomiting, and diarrhea.