|Approval Dates and Comments
The European Commission (EMEA) granted orphan medicinal product designation in April 2001, for the treatment of multiple myeloma and myelodysplastic syndromes.
The regulatory authorities in the Netherlands approved this transdermal therapy in March 2001, for the treatment of menopausal symptoms and for the prevention of postmenopausal osteoporosis.
Barr Laboratories/ DuPont Pharmaceuticals
The US FDA approved this proprietary product in March 2001, for the treatment of neoplastic disease, psoriasis and rheumatoid arthritis. Trexall represents new dosage strengths in 5, 7.5, 10, and 15mg tablets.
The US FDA sent letters to four internet retailers in March 2001, to caution them that advertising and selling colloidal silver as a cure for conditions ranging from sunburn to sinus infections and allergies violates the agency’s regulations, since the products have not undergone the FDA approval process for new drugs. They cannot be considered dietary supplements if they claim to prevent, diagnose, mitigate, treat or cure a disease. Furthermore, dietary supplements are, by law, ingestible, so that promotion of colloidal silver in topical formulations for conditions such as sunburn, acne and rashes further invalidates the products’ status as supplements. Four of the sites to receive letters from the FDA are Synergy Systems, Soul Healer, survival.com, and rawhealth.net.
Preliminary phase III data for the antibacterial product Cidecin (Daptomycin for injection, Cubist Pharmaceuticals) has shown it to be as effective as comparable agents in treating complicated skin and soft tissue infection resulting from gram-positive bacteria.
Researchers at the University of Muenster in Germany report that capsaicin, an herb that inhibits a peptide transmitter involved in pain transmission (substance P), relieved pruritus and promoted the healing of skin lesions in 33 patients with prurigo nodularis.* Pruritus was completely eliminated in all patients by day 12 of treatment. However, it returned within 2 months after the treatment was discontinued. *J Am Acad Dermatol 44:471–78 (2001)
With assistance from the World Bank of $30 million USD, India is launching the second phase of its national leprosy elimination project. Over 2/3 of the world’s leprosy patients live in India, and officials from the World Health Organization (WHO) say that India’s role for global leprosy elimination is absolutely critical. The project will assist in identifying new cases early, providing appropriate uninterrupted multi-drug therapy to prevent disabilities, and helping to locate and treat patients among previously inaccessible groups.