Merck & Co.

U.S. FDA approves INVANZ for treatment complicated foot infection in diabetic patients

Published in Pharma Investments, Ventures and Law Weekly, December 18th, 2005

Merck & Co., Inc. announced that the U.S. Food & Drug Administration (FDA) has approved INVANZ (ertapenem), a once-daily injectable antibiotic, for the treatment of moderate-to-severe complicated foot infection due to indicated pathogens in diabetic patients without osteomyelitis.

The approval was based on the results of the SIDESTEP study, according to the company the largest prospective, randomized, and double-blind clinical trial ever conducted in diabetic patients with moderate-to-severe complicated foot infection. Foot infections commonly occur in patients with diabetes and are known to be difficult to treat.

"Currently there are limited data...

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Source: Pharma Investments, Ventures and Law Weekly (2005-12-18)

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