Resources for Food and Drug Administration (FDA)

FDA Approves 19 New U.S. Drugs, Fewest Since '83; Glaxo Leads

www.bloomberg.com

The U.S. Food and Drug Administration approved 19 new drugs in 2007, the fewest in 24 years, after drugmakers focused on developing uses for existing products.

The number of new medicines, including those made with novel chemical ingredients and using biotechnology, was three less than in 2006. Last year's approvals were tallied by analyst Ira Loss, and the FDA declined to confirm the numbers.

Drugmakers such as GlaxoSmithKline Plc say the FDA raised its standards for approvals, an assertion the agency denies. Companies shifted emphasis to altering drugs and seeking more diseases to treat with them, at the expense of developing new products, said Kenneth I. Kaitin, director of the Tufts University Center for the Study of Drug Development in Boston.

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