The following database contains products that have been granted orphan status, or have been market approval in the EU or the USA.

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Country Product Indication Sponsor Date
Midodrine HCl Patients with symptomatic orthostatic hypotension Shire;725 Chesterbrook Blvd;Wayne, Pennsylvania, 19087 June 21, 1985
Prednimustine Malignant non-Hodgkin's lymphomas Pharmacia Inc.;P.O. Box 16529;Columbus, Ohio, 43216 June 17, 1985
Anagrelide Polycythemia vera Roberts Pharmaceutical Corp.;Meridian Center II, Four Industrial Way West;Eatontown, New Jersey, 07724 June 11, 1985
Gancyclovir Severe human cytomegalovirus infections in specific immunosuppressed patient populations Burroughs Wellcome Company;3030 Cornwallis Road, P.O. Box 12700;Research Triangle Park, North Carolina, 27709 June 7, 1985
Surface active extract of saline lavage of bovine lungs Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants ONY, Inc.;1576 Sweet Home Road;Amherst, NY, 14228 June 7, 1985
Calfactant surfactant deficiency ONY, Inc.;1576 Sweet Home Road;Amherst, New York, 14228 June 7, 1985
Tretinoin Squamous metaplasia of the ocular surface epithelia (conjunctiva and/or cornea) with mucous deficiency and keratinization Hannan Ophthalmic Marketing Services, Inc;34 Sherrill Rd.;Marshfield, Massachusetts, 02050 April 15, 1985
Oxymorphone For relief of severe intractable pain in narcotic-tolerant patients DuPont Merck Pharmaceutical Company;P.O. Box 80027;Wilmington, Delaware, 19880 March 19, 1985
Naltrexone HCl For blockade of the pharmacological effects of exogenously administered opioids as an adjunct to the maintenance of the opioid-free state in detoxified formerly opioid-dependent individuals DuPont Pharmaceuticals;E.I. Du Pont De Nemours & Co.;Wilmington, Delaware, 19898 March 11, 1985
Digoxin immune fab(ovine) Life-threatening acute cardiac glycoside intoxication manifested by conduction disorders, ectopic ventricular activity and (in some cases) hyperkalemia Boehringer Mannheim Corp.;1301 Piccard Drive;Rockville, Maryland, 20850 March 11, 1985
Alglucerase injection Gaucher disease Genzyme Corporation;One Kendall Square;Cambridge, Massachusetts, 02139 March 11, 1985
Superoxide dismutase (human) For protection of donor organ tissue from damage or injury mediated by oxygen-derived free radicals that are generated during the necessary periods of ischemia (hypoxia, anoxia), and especially reperfusion, associated with the operative procedure Pharmacia-Chiron Partnership;4560 Horton Street;Emeryville, California, 94608 March 6, 1985
Epidermal growth factor (human) For promotion of cutaneous wound healing in extreme burn treatment protocols Ethicon, Inc.;P.O. Box 151;Somerville, New Jersey, 08876 March 6, 1985
Antipyrine Test For use as an index of hepatic drug-metabolizing capacity Upsher-Smith Laboratories, Inc;4905 23rd Avenue North;Minneapolis, Minnesota, 55447 February 21, 1985
Antithrombin III (human) For the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism Pharmacia & Upjohn AB;Lindhagensgatan 133, Stockholm; February 8, 1985
Erwinia L-asparaginase Acute lymphoblastic leukemia Lyphomed, Inc.;; January 25, 1985
Levomethadyl acetate hydrochloride Heroin addicts suitable for maintenance on opiate agonists Biodevelopment Corporation;8180 Greensboro Drive, Suite 1000;McLean, Virginia, 22102 January 24, 1985
Gamma-hydroxybutyric acid Narcolepsy Sigma Chemical Company;; January 22, 1985
Factor XIII concentrate (human) Factor XIII Deficiency CSL Behring LLC;1020 First Ave., PO Box 61501;King of Prussia, Pennsylvania, 19406 January 16, 1985
Flumecinol Hyperbilirubinemia in newborn infants unresponsive to phototherapy Farmacon, Inc.;Post House, Suite 213, 1720 Post Road East;Westport, Connecticut, 06880 January 15, 1985
Protirelin injection Amyotrophic lateral sclerosis Abbott Laboratories;200 Abbott Park Road;Abbott Park, Illinois January 10, 1985
Trientine HCl Wilson disease Merck Sharp & Dohme Research;Division Of Merck And Company;West Point, Pennsylvania, 19486 December 24, 1984
Sodium monomercaptoundecahydro-closo-dodecaborate Glioblastoma Theragenics Corporation;; December 18, 1984
Amsacrine Acute adult leukemia Warner-Lambert Company;2800 Plymouth Road;Ann Arbor, Michigan, 48106 December 7, 1984
Alpha1-proteinase inhibitor (human) For replacement therapy in the alpha-1-proteinase inhibitor congenital deficiency state Bayer Corporation;Pharmaceutical Division, Biological Products, 400 Morgan Lane;New Haven, Connecticut, 06516 December 7, 1984