Drug Approvals Up

The total number of new drugs approved this year ties last year for the highest since 2004, suggesting that the pharmaceutical industry is recovering.

By | December 7, 2012

Wikimedia, Tom VarcoThe US Food and Drug Administration (FDA) approved 35 innovative new drugs in the fiscal year that ended September 30, 2012, one of the highest totals in recent years, according to a report released by the agency this week (December 5).

The total matches that of last year, and is the highest it’s been since 2004, when 36 new medicines were passed. In the intervening years, the number fell to little more than half its current level. Because drug approvals often reflect the number of applications filed in the previous year, the report may be indicative of a healthier and more productive pharmaceutical industry.

The FDA claims that the figures also reflect improvements in its approval process. “Most of the drugs were approved for US patients before they were available in other countries, and the efficiency of the drug review process continued to grow,” the report read. Indeed, of the 32 drugs also approved in other countries, 24 were first approved in the U.S., and 77 percent of them were approved in the first cycle of review, without the requirement for additional information that would slow the process.

Among the novel drugs approved last fiscal year were 10 cancer medicines, including the first for basal skin cancer; treatments for HIV and macular degeneration; a meningitis vaccine; and the first drug to target the genetic basis of cystic fibrosis. There were also nine new drugs for orphan diseases, which effect a tiny percentage of the population.


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