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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  3. Medical products for rare diseases and conditions
  4. Designating an Orphan Product: Drugs and Biological Products
  5. Instructions for Searchable Designation Database
  1. Designating an Orphan Product: Drugs and Biological Products

Instructions for Searchable Designation Database

During searches, if more than one field is populated, results of the search will display as if the word 'and’ was put between the search criteria. For example, searching 'interferon' as a product and 'lymphoma' as a designation will return only matches where both criteria are met. If you search each criteria individually (i.e., an 'or' search), the search must be run separately. Running a default search with no criteria will return all designations.
 

Orphan Drug Designations and Approvals

 

Product Name or Designation

Entering a search term will find any occurrence of the term in either the product name or designation fields. For example, searching 'penicil' as a product name would return 'penicillin', 'aminopenicillin', and 'penicillinase'. Both generic names and tradenames when available may also be searched. Searching the designation field is similar to searching the product name field. For example, searching 'malaria' as a designaton would return 'Treatment of malaria' or any other designation containing the term malaria.

Date Ranges

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' will retrieve all products receiving orphan designation during that period.

Only Approved Products

Searches can return all designations or be restricted to products that are FDA-approved for the Orphan Designation. The default is all designations. Selecting 'Only approved products' will return only products that have received marketing approval for the orphan designation during that period.

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