Latebreakers: 2007: Fewest new entities approved by FDA in 24 years

January 28, 2008

FDA approves 19 new drugs in 2007

According to analyst Ira Loss of Washington Analyst, the FDA approved 19 new entities in 2007, including 17 new molecular entities (NMEs) and two new biologics. The numbers have not been confirmed by the agency, but represent the lowest number of approvals in one year since 1983. In 2006, the FDA approved 18 NMEs and four biologics. Some pharmaceutical manufacturers say the decrease in new drugs is due to higher FDA standards for approval, while others say the drug companies themselves are focusing on new uses for medications already on the market, rather than seeking approval of new drugs.