The Food and Drug Administration today announced improved results over last year on overall drugs and biologics approvals for calendar year 2003, and decreases in the time it took the Agency to review and approve most applications.A highlight of this success was the approval of 21 New Molecular Entities (NMEs) with active ingredients never before marketed in the United States. This number of NME approvals is up from the calendar year 2002 total of 17. Priority approvals – approvals for priority products of special medical importance – increased from 2002 as well: there were 14 priority NDAs and 9 priority NMEs, compared to 11 and 7 in 2002, respectively.
