Historical Perspective

A new drug application (NDA 12-611) was originally submitted for thalidomide in September 1960 to the then Bureau of Medicine (a precursor to the FDA) (8). It was being indicated for use in the treatment of somnolence and as a mild hypnotic. At that time thalidomide was widely used in Europe and was considered a safe and effective sedative. The application was found to have significant shortcomings by three reviewers and additional data was requested. In February 1961 reports emerged of peripheral neuritis occuring in individuals receiving long-term treatment with thalidomide, a further delay in the application, which caused review. In addition, concerns were starting to be raised about possible adverse effects to the fetus if administered during pregnancy. In November 1961 the application was put on hold and subsequently withdrawn because of data from Germany suggesting an association between phocomelia (a rare birth defect) and thalidomide. In 1965 efficacy was reported in the treatment of leprosy; this was later verified in large clinical trials. In addition, immunosuppression activity was detected in a skin model as well as efficacy in preventing GVHD. More recently, the FDA has approved the use of thalidomide for the treatment of skin lesions and fever-associated erythema nodusum leprosum in patients with leprosy.

How To Deal With Rosacea and Eczema

How To Deal With Rosacea and Eczema

Rosacea and Eczema are two skin conditions that are fairly commonly found throughout the world. Each of them is characterized by different features, and can be both discomfiting as well as result in undesirable appearance features. In a nutshell, theyre problems that many would want to deal with.

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