Sulfadiazine Gains US Approval

Eon Labs' sulfadiazine, for the treatment of toxoplasmosis, has gained an Abbreviated New Drug Appli-cation approval from the US Food and Drug Administration. The license was granted under an expedited review.

The approval ends the absence of an approved domestic US source for the drug and should go some way to alleviating a shortage of it in the USA. The Centers for Disease Control & Prevention began purchasing sulfadiazine from Canadian manufacturer Stanley Pharmaceuticals in 1993 and distributing it free under an Investi-gational New Drug application.

Since it began distribution of the product, the CDC has released the drug to 2,000 toxoplasmosis patients, most with AIDS. The drug, according to the FDA, is particularly useful in treating toxoplasmosis encephalitis, for which it has an orphan drug designation. The drug is also useful in sulfa-sensitive patients.