FDA FDA Home? Developing Products for Rare Diseases & Conditions* Search Orphan Drug Designations and Approvals (S)-1-(4-(1-(3,4,5-trimethyloxypheny|)-1H-imidazol-4- Generic Name: ylamino)thieno[2,3-d]pyrimidin-2-yl)pyrrolidine-2- carboxamide citrate Date Designated: 08/29/2022 Orphan Designation: ‘Treatment of fibrodysplasia ossificans progressiva Orphan Designation Status: Designated FDA Orphan Approval Status: Not FDA Approved for Orphan Indication BioCryst Pharmaceuticals, Inc. 4505 Emperor Blvd., Suite 200 Nottingham Hall Sponsor: Durham, North Carolina 27703 United States The sponsor address listed isthe lest reported by the sponsor to OOD. *€xclusivity Protected Indications are shown for approvals from Jan, 1, 2013, to the present. Links on this page: 1. http://www.addthis.com/bookmark.php?uS0: 2. http://www.addthis.com/bookmark.php 3. https://www.fda.gov/ 4. http://www.fda.gov/Forindustry/DevelopingProductsforRareDiseasesConditions/defeult. htm Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players, Language Assistance Available: Espafiol | #983 | Tiéng Viét | $04 | Tagalog | PyccKiit | 44»! | Kreydl Ayisyen | Francais | Polski | Portugués | Italiano | Deutsch | El | +.8 | English Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Nondiscrimination Website Policies / Privacy FDA U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA t HOR & For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Vulnerability Disclosure Policy u. jepartnent of Health & Hur Services Links on this page: 1. http://www.addthis.com/bookmark.php?uS0 2. http://www.addthis.com/bookmark.php.3. https://www.fda.gov/ 4. http://www.fda. gov/Forindustry/DevelopingProductsforRareDiseasesConditions/default.htm