• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

NDA Approvals by Therapeutic Potential and Chemical Type

YearTherapeutic Potential - Priority Review*
and Chemical Type***
Therapeutic Potential - Standard Review**
and Chemical Type***
Total Approvals
1234567Total123456

 

7

Total
199012080000201122322404464
1991140500001916115210004463
1992110501001715130521117491
1993130600001912018118205170
1994130400-017902358-04562
199591500-01519530211-06782
19961801001-0293555047-1102131
199791613-02030252124-1101121
1998160900-0251404640-16590
1999191710-0281623232-05583
200091910-0201804873-27898
200171101-0101712395-15666
200270310-0111024456-06778
 200390410-0 141253173-0 58 72
 2004170413-0 251415958-1 88 113

 

 *Priority Review - Significant improvement compared to marketed products in the treatment, diagnosis, or prevention of a disease.

 **Standard Review - The drug appears to have therapeutic qualities similar to those of one or more already marketed drugs.

***Chemical Types:
     1 -   New molecular entity
     2 -   New ester, new salt, or other noncovalent derivative
     3 -   New formulation
     4 -   New combination
     5 -   New manufacturer
     6 -   New indication (Beginning in 1994, Type 6 NDAs were tracked as efficacy supplements)
     7 -   Drug already marketed, but without an approved NDA

Updated through 12/31/2004

-
-