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NEW YORK — This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.
The Wall Street Journal reported that 21 new drugs were approved through the year, compared with 25 in 2009 and 24 in 2008. The lag came in part due to stricter safety regulations, the newspaper reported.
One drug that experienced a delay was MannKind Corp.’s inhaled insulin Afrezza (insulin human [rDNA origin]); the FDA informed the company at the end of December that it would require four additional weeks to complete its review of the application for the drug.