FDA approves 20 new biotech products

March 1, 2003

Pharmaceutical Representative

The FDA issued 35 approvals for new biotechnology-based drugs and vaccines as well as new indications for previously approved products in 2002.

The Food and Drug Administration issued 35 approvals for new biotechnology-based drugs and vaccines as well as new indications for previously approved products in 2002, up slightly from 2001, according to an analysis by the Washington-based Biotechnology Industry Organization.

"More than half of the 155 biotech medicines available to patients and on the market today were approved in just the last five years, demonstrating the steadily accelerating growth of the biotech industry," said Carl B. Feldbaum, BIO president.

Many types of treatments

Of the 35 FDA biotech approvals issued last year, 20 were for new medicines designed to treat such diseases as osteoporosis, hepatitis C, pulmonary arterial hypertension, cancer and multiple sclerosis.

"The increase in the number of FDA biotechnology product approvals last year means that many patients with debilitating and life-threatening illnesses now have their first-ever therapies and cures, and many others have vastly improved medical options available to them," Feldbaum said. "More than 350 biotech products are in late-stage development for 200 serious diseases, and many of these represent significant medical advancements for patients suffering from conditions such as asthma, diabetes and HIV infection."

Feldbaum added that The Prescription Drug User Fee Act, which was renewed last year, should continue to help reduce review and approval times at the FDA. "With that law in place and a new commissioner leading the agency, the drug approval process will continue to improve." PR

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