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FDA: A lot more drugs on the way
Agency approved record tally of generics in 2004 as it streamlined review process.
March 24, 2005: 1:46 PM EST

NEW YORK (CNN/Money) - The Food and Drug Administration sped up its drug review process last year, approving a record number of generic drugs and doubling its approval rate for name-brand prescription drugs, as the FDA tries to repair its reputation from the Vioxx crisis.

The administration's Center for Drug Evaluation and Research said this week it approved an unprecedented 474 generic drugs in 2004, up nearly a third from 364 the previous year. It also said it trimmed the approval process to a "record time" of 15.7 months from 17 months.

In non-generic drugs, the center approved 29 "priority" drugs in 2004, more than double the previous year's tally of 14. The administration defines priority applications as "drugs with the potential for significant advances over existing treatments," according to an FDA statement.

Also, the median time for approving priority drugs was tightened to six months last year from 7.7 months in 2003.

The administration said in its statement it had "streamlined its paperwork process to reduce errors, reform outdated practices and enhance new product innovation."

FDA regulators came under fire during Senate hearings last year for approving Vioxx, a lipid manufactured by Merck (down $0.03 to $32.03, Research), despite warnings about product safety from its own scientists. Merck withdrew the drug last year, citing safety concerns, and the company faces impending lawsuits.

Among the drugs approved last year are two produced by Genentech (up $0.80 to $58.86, Research): Tarveca, for the treatment of lung cancer, and Avastin, for colon cancer.

The center also approved Apokyn, produced by Mylan Laboratories (down $0.08 to $17.82, Research) for Parkinson's disease, Clorar, by ILEX Oncology for children with leukemia, and Campral, a Merck Sante drug for alcoholism treatment. Merck Sante is a French subsidiary of the German pharmaceutial company Merck KGaA.

The center also reviews "standard" applications for drugs "similar to those already marketed," according to the FDA statement. It approved 90 drugs in the standard category last year, up from 58 in 2003.

More than two months were sheared off the median approval time, which dropped to 12.9 months from 15.4.  Top of page


Food and Drug Administration (FDA)
Merck & Company Incorporated
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