FDA rejects Advancis' NDA on strep therapy

The FDA has rejected Advancis Pharmaceuticals' NDA for a new strep throat therapy, saying it cannot be approved in its current form. In a letter, the FDA explained that it had questions about how Advancis plans to scale up its manufacturing process. Advancis, which says it was surprised by the letter, plans to meet with the agency to discuss its concerns. Advancis' trial on Amoxicillin Pulsys failed in 2005 but was successfully completed last summer.

- read the report on the FDA's action from the Washington Business Journal