If a product receives an orphan drug designation, certain information (sponsor’s name, address and contact information, name of drug, orphan designated use and date of designation) about the orphan designated product is posted in the searchable database on the OOPD website.
Per 21CFR 316.28(b), FDA will post the generic and trade name of the drug, or if neither is available, the chemical name or a meaningful descriptive name of the drug provided by the sponsor and subject to approval by OOPD.
If a designated product is approved for marketing, certain additional information is available on the website (approval date, approved indication, and exclusivity status).
