Table 3 Withdrawn orphan drug designations between 1983 and 2013 for compounds intended to treat rare rheumatologic disorders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