FDA Application
Search Orphan Drug Designations and Approvals
This page searches the Orphan Drug Product designation database. Searches can be limited to specific dates, products, and indications. Results can be output as a condensed list, detailed list, or an Excel spreadsheet. More detailed 
instructions are described below. It is highly recommended that large searches be retrieved as an Excel file (selected under Output format) since only a maximum of 75 records can be displayed at one time. The database currently contains more than 1800 records.
Instructions:
During searches individual fields are 'anded' together, e.g., searching 'interferon' as a product and 'lymphoma' as a designation will return only matches where both criteria are met. If you wish each criteria individually (i.e., an 'or' search), the searches should be run separately. Running a default search with no criteria will return all designations.
Product Name or Designation
Entering a search term will find any occurrence of the term in the product name or designation. For example searching 'penicil' as a product name would return 'penicillin', 'aminopenicillin','penicillinase', etc. Both generic names (and tradenames when available) are searched. Searching designations is similar; searching 'malaria' would return 'Treatment of malaria' or any other designation containing the term malaria. If product name, designation, or both are left blank, all products meeting the other search criteria will be returned. Booleans operators (i.e., 'and' or 'or') cannot be used with searches. Return to Product Name entry Return to Designation entry
Search dates
Enter start and end dates for searches. Dates searched will be for all products designated during the specified period unless the search is restricted to products that have received marketing approval for the orphan designation, in which case the dates searched will be the dates the product was approved for the orphan indication. For example, entering '9/3/2008' and '1/24/2009' as the start and end dates respectively and selecting 'All designations' below (the default) will retrieve all products receiving orphan designation during that time; selecting 'Only approved products' will return only products that have received marketing approval for the orphan designation during that period. Return to Start Date entry
Restrict Search Results
Searches can return all designations or be restricted to products that are FDA-approved for the Orphan Designation. The default is all designations. Return to Search Results entry
Output Format:
Results can be displayed on the screen in condensed format (Generic name, Orphan Designation, and date of Orphan Designation only), Detailed (complete information on each designation), or downloaded as an Excel file. If displayed, the number of records specifies how many records are returned on each page displayed: the default is 25 records per page (maximum is 75). Output can also be sorted by generic name or by date in either chronological (earliest first) or reverse chronological order (most recent first.) Return to Output Format entry