December 14, 2007

On Drug Details pages for newly approved drugs, you may see the abbreviation "TBD" ("To Be Determined") and an icon in the "RLD" or "TE Code" column.  The "TBD" code indicates that FDA has not yet determined Reference Listed Drug status for the recently approved product or that FDA has not yet determined Therapeutic Equivalence for the product.

April 27, 2007

The link to the "Downloadable Database File" no longer appears on the Drugs@FDA home page.  The page remains available at http://www.fda.gov/cder/drugsatfda/datafiles.  The Drugs@FDA FAQ also provides a link to the database file information.  Look for: "Can I get a copy of the Drugs@FDA database?"

November 2, 2006

FDA's Center for Drug Evaluation and Research launches Version 2 of Drugs@FDA, adding these new features:

• Drug Approval Reports by Month

A new link on the Drugs@FDA Home Page takes you to "Drug Approval Reports by Month."  There are five different reports available:

• All Approvals by Month
• Original New Drug Approvals (NDAs and BLAs)
• Original Abbreviated New Drug Approvals (ANDAs)
• Supplements to New Drug Applications (NDAs and BLAs)
• Tentative Approvals
  
  
• Searching
  • You can now search for Application Numbers on the Home Page. You no longer have to go to "Advanced Search."
    
  • NDA number searches no longer require all six digits. For example, you can now enter:
    020764, 20764, or 20-764
    
    
• Search Results and Other Displays
  • You will jump directly to the "Drug Details" page (skipping the Search Results and Overview) if there is only one match for your search.
  • Sorting: You can re-sort a table by clicking on a linked column header.
  • The "Drug Details" Page now lists the following additional information, where applicable:
    • Review Classification
    • Chemical Type (for NDAs)
    • Original Approval Date