us fda committee recommends thalidomide approval

22 MARKET NEWS US FDA commiHee recommends thalidomide approval Following a 2-day meeting, a US FDA advisory committee voted 8-2 to recommend the approval of thalidomide for the treatment of erythema nodosum leprosum in patients with leprosy. This condition affects approximately 2 million people worldwide. A member of the American Academy of Paediatrics commented that he was 'deeply concerned' about the use of thalidomide, pointing out that even with an extensive public education programme there would be potential for a 'devastating increase in birth defects'. The FDA committee said that it wanted to bar off-label use of the drug and restrict it for use only in the treatment of erythema nodosum leprosum. Furthermore, physicians and pharmacists will have to be certified to prescribe or dispense thalidomide. Celgene, the company which sought approval of its thalidomide product, has proposed restricted distribution through select pharmacies and close monitoring of thalidomide recipients. FDA panel urges approval of thalidomide for erythema nosdoswn leproswn. Reuters Health [online): [2 pages). 8 Sep 1997. Available from: URL: bttp:l/www.reutershealth.com 800S61S41 Inpharma- 13 Sap 1997 No. 1104 1173-8324197/1104-000221$01.00° Adls International Limited 1997. All rlghta reserved

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Page 1: US FDA committee recommends thalidomide approval

22 MARKET NEWS US FDA commiHee recommends thalidomide approval

Following a 2-day meeting, a US FDA advisory committee voted 8-2 to recommend the approval of thalidomide for the treatment of erythema nodosum leprosum in patients with leprosy. This condition affects approximately 2 million people worldwide.

A member of the American Academy of Paediatrics commented that he was 'deeply concerned' about the use of thalidomide, pointing out that even with an extensive public education programme there would be potential for a 'devastating increase in birth defects'. The FDA committee said that it wanted to bar off-label use of the drug and restrict it for use only in the treatment of erythema nodosum leprosum. Furthermore, physicians and pharmacists will have to be certified to prescribe or dispense thalidomide.

Celgene, the company which sought approval of its thalidomide product, has proposed restricted distribution through select pharmacies and close monitoring of thalidomide recipients. FDA panel urges approval of thalidomide for erythema nosdoswn leproswn. Reuters Health [online): [2 pages). 8 Sep 1997. Available from: URL: bttp:l/www.reutershealth.com 800S61S41

Inpharma- 13 Sap 1997 No. 1104 1173-8324197/1104-000221$01.00° Adls International Limited 1997. All rlghta reserved

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