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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.
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]
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
NanoViricides Announces that DengueCide™ Has Received Orphan Drug Designation From the US FDA WEST HAVEN, Conn.--(BUSINESS WIRE)-- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced ...
NanoViricides Submits DengueCide™ Orphan Drug Designation Application to the US FDA for Dengue and Dengue Hemorrhagic Fever WEST HAVEN, Conn.--(BUSINESS WIRE)-- NanoViricides, Inc. (OTC BB: NNVC ...
The FDA granted the application for vanzacaftor, tezacaftor, and deutivacaftor combination therapy orphan drug designation. [5] Society and culture. Legal status
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Nipocalimab has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the prevention of HDFN. [3] Additionally, FDA granted nipocalimab orphan drug designation in HDFN. [4] [5] In 2019, nipolcalimab received orphan medicinal product designation by the European Medicines Agency for the treatment of HDFN ...