Skip to main content

Table 3 Withdrawn orphan drug designations between 1983 and 2013 for compounds intended to treat rare rheumatologic disorders

From: Novel treatments for rare rheumatologic disorders: analysis of the impact of 30 years of the US orphan drug act

Withrawn compound Designation year Designated indication according to FDA database
Dimethyl sulfoxide 1986 Cutaneous manifestations of scleroderma
Guanethidine monosulfate 1986 Moderate to severe reflex sympathetic dystrophy and causalgia
Bromhexine 1989 Mild to moderate keratoconjunctivitis sicca in patients with Sjögren’s syndrome
Immune globulin intravenous (human) 1992 Juvenile rheumatoid arthritis
Immune globulin intravenous (human) 1992 Polymyositis/dermatomyositis
AI-RSA 1992 Autoimmune uveitis
Methotrexate 1993 Juvenile rheumatoid arthritis
Dehydroepiandrosterone 1994 Systemic lupus erythematosus (SLE) and the reduction in the use of steroids in steroid-dependent SLE patients
Interferon beta-1a 1998 Juvenile rheumatoid arthritis
Humanized MAb (IDEC-131) to CD40L 1999 Systemic lupus erythematosus
Etanercept 1999 Wegener’s granulomatosis
pVGI.1 (VEGF2) 1999 Thromboangiitis obliterans
Infliximab 2003 Giant cell arteritis
Human Anti-tumor Necrosis factor alpha monoclonal antibody 2003 Uveitis of the posterior segment of non-infectious etiology, and uveitis of the anterior segment of non-infectious etiology and refractory to conventional therapy
Golimumab 2004 Chronic sarcoidosis