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In contrast, the decade prior to 1983 saw fewer than ten such products come to market. From the passage of the ODA in 1983 until May 2010, the FDA approved 353 orphan drugs and granted orphan designations to 2,116 compounds. As of 2010, 200 of the roughly 7,000 officially designated orphan diseases have become treatable. [13]
This encouraged the FDA to use the Orphan Drug Act to help bolster research in this field, and by 1995 13 of the 19 drugs approved by the FDA to treat AIDS had received orphan drug designation, with 10 receiving marketing rights. These are in addition to the 70 designated orphan drugs designed to treat other HIV related illnesses. [21]
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
The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases ...
Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis; [3] [23] re-approved in June 2020 for the treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules. Fenoterol: 1990 New Zealand Asthma mortality. [3] Feprazone: 1984 Germany, UK Cutaneous reaction, multiorgan toxicity. [3] Fipexide: 1991 France ...
FDA’s Office of Orphan Drug Products grants Orphan Drug Designation (ODD) to support the development of medicines for rare disorders that affect fewer than 200,000 people in the US. Under the Orphan Drug Act, ODD qualifies a company for incentives, including tax credits, exemptions from certain FDA fees for clinical trials, and the potential ...
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
Amifampridine phosphate is used as a drug, predominantly in the treatment of a number of rare muscle diseases. The free base form of the drug has been used to treat congenital myasthenic syndromes and approved by the FDA for Lambert–Eaton myasthenic syndrome (LEMS) through compassionate use programs since the 1990s and was recommended as a first line treatment for LEMS in 2006, using ad hoc ...