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Lists of all drugs that have received orphan status in the United States and Europe are available from the U.S. Food and Drug Administration and the European Commission, respectively: FDA List of Orphan Designations and Approvals [dead link ] European Commission Register of designated Orphan Medicinal Products
[2] [3] [4] Only thirty-eight orphan drugs had been approved prior to the 1983 Act; by 2014 "468 indication designations covering 373 drugs have been approved." [5] Partly as a result of the 1983 US Orphan Drug Act, Japan adopted it in 1993 as did the European Union in 2000. [5]
In the US, from January 1983 to June 2004, 249 orphan drugs received marketing authorization and 1,129 received different orphan drug designations, compared to fewer than ten such products in the decade prior to 1983. From 1983 until May 2010, the FDA approved 353 orphan drugs and granted orphan designations to 2,116 compounds.
Orphanet is an organisation and knowledge base dedicated to rare diseases as well as corresponding diagnosis, orphan drugs, clinical trials and expert networks. [1] Orphanet was founded in France in 1997 by Inserm, the French National Institute of Health and Medical Research. The website is managed by a network of academic establishments from ...
Orphan drug status, which is given to drugs meant for the treatment of rare diseases, offers drug developers a path to faster approval and enhanced market exclusivity. So let's look at a small ...
Brand name Manufacturer Indication Elrexfio: To treat relapsed or refractory multiple myeloma after at least four lines of therapy [1] Fabhalta: To treat paroxysmal nocturnal hemoglobinuria [1] Izervay: To treat geographic atrophy secondary to age-related macular degeneration [1] Leqembi: To treat Alzheimer's disease [1] Loqtorzi
Lucinactant is listed as an Orphan Drug Product by the US Food and Drug Administration for several conditions: [9] [10] 07-30-1996 Treatment of meconium aspiration syndrome in newborn infants; 07-17-1995 Treatment of acute respiratory distress syndrome in adults. 05-23-2006 Prevention of bronchopulmonary dysplasia in premature infants
Advaxis Requests Orphan Drug Designation for Treatment of HPV-Associated Head and Neck Cancer with ADXS-HPV -- Orphan Drug Designation Could Provide Significant Financial Incentives and Serve an ...