The 35 new drug application approvals by the FDA through May exactly match 2005 and 2006 approval levels and reflect 40 percent year-over-year growth from 25 at the same time last year, writes James Kumpel of Friedman Billings Ramsey, in an investor note this morning.

But, he adds, “looks can be deceiving.” “Fully 40 percent of the NDA approvals constitute new manufacturers for existing compounds, approvals of drugs that had already been marketed, or new formulations of existing compounds. Aside from those approvals, the comparison would have been 21 year-to-date in 2008 versus 16 in the comparable year-ago period.”

Meanwhile, the number of new molecular entities, or NMEs, approved are still “moribund,” as he puts it. Year-to-date totals amount to just five, “which barely exceeds the 10-year low of four reached in 2005 and reflects a 17 percent year-over-year decline from comparable 2007 levels and a 39 percent shortfall versus the 10-year average of 8.2,” Kumpel continues.

The bottom line: “Until we see the productivity benefits of an FDA staffing push,” Kumpel concludes, “we expect the risk-averse agency to approve relatively few new breakthrough drugs in 2008.”