FDA MISSES RECORD YEAR FOR NEW DRUG APPROVALS

The FDA approved eight new drug applications (NDAs) in December, ending 2006 with 13 more approvals than in 2005 but 19 fewer than in 2004.

After a surge of approvals in October, analysts predicted 2006 would be a record year for NDA approvals. At that point, the agency had approved 83 NDAs, the same number as at that time in 2004, the best year for approvals during the Bush administration.

The agency did not maintain its record pace, however, and approved only two NDAs in November, the slowest month for approvals for the year. The eight December approvals matched the number of approvals for that month in 2005, but were well below the 18 approvals in December 2004.

For the year, the FDA approved 93 NDAs, up from 79 in 2005 but down from 112 in 2004. The agency received 123 NDAs total during 2006, up slightly from previous years. The same trend held true for the agency's approval of new molecular entities (NMEs). The agency approved 18 NMEs in 2006, the same as in 2005, which was down from 31 in 2004, the best year for NME approvals since 1999.

The agency approved five NMEs in December after not approving any in November, one of four months in which the agency did not approve any NMEs.