FDA approves 19 new U.S. drugs, fewest since ’83

WASHINGTON -- 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.

``They got away from their core mission, which was to bring new medicines and new treatments to market,’’ Kaitin said in an interview Tuesday. ``If you’re putting money into extending the lifecycle of a drug on the market, you’re taking money away from a drug development program.’’

The companies are getting back to developing new treatments, and the annual approval numbers should increase in coming years, Kaitin said.

Approvals included Glaxo’s Tykerb for breast cancer and Novartis AG’s Tasigna for leukemia.

The FDA’s Web site lists 14 “new molecular entities,’’ or novel chemical treatments, approved through November of last year.

Three more were approved in December, bringing the total to 17, according to Loss, who tracks the FDA for Washington Analysis in Washington, D.C.

In addition, the agency cleared two new treatments last year that use biotechnology, gene-based products derived from living organisms, Loss said.

The combined total of approvals is the lowest since 1983, according to the Tufts drug development center. In that year, there were 14 new drugs approved, none of them biotechnology products.

The FDA hasn’t tallied the approvals for last year and couldn’t confirm the number, said agency spokesman Christopher DiFrancesco. He said he wasn’t sure when the agency’s annual data on new drug applications and approvals would be ready.

Novartis, based in Basel, Switzerland, and Glaxo of London each had two new drugs approved in 2007, the most of any companies.

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