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FDA approves first orally administered botanical drug

04-Jan-2013

For the first time, FDA has approved an orally administered botanical as a new drug, the American Botanical Council reports.

On Dec. 31 the agency approved crofelemer, under the brand name of Fulyzag from Raleigh, NC-based Salix Pharmaceuticals Ltd, for use in treating HIV-related diarrhea. In 2006 the agency had approved as a drug a topical containing green tea.

Crofelemer is derived from the latex of the South American sangre de drago tree (dragon's blood, Croton lechleri). A red, blood-resembling latex leaks from the tree when its bark is cut, and it is this substance that contains the novel polymolecular structure crofelemer, originally developed and standardized by Shaman Pharmaceuticals.

According to FDA, in a trial of 374 HIV-positive participants, 17.6% showed a positive clinical response with the new drug as opposed to 8% in the placebo group.

Salix says it plans to have the drug available for prescription in early 2013. According to ABC, a Bloomberg analysis predicts sales of the drug of of $18 million in 2013 and $26 million in 2014.

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