Salix Pharmaceuticals Ltd. has announced that the Food and Drug Administration is extending the review period for the company’s new drug crofelemer, a treatment for non-infectious diarrhea in HIV/AIDS patients on antiretroviral therapy. Earlier, FDA had set Wednesday as the day its review would be complete; now a regulatory decision is expected by the end of the first quarter of 2013. “By taking no action at this time, the FDA has allowed for the currently ongoing dialogue between Salix and the FDA to continue,” said a statement from Bill Forbes, the company’s chief development officer. Discussions are centering on the production and control of the drug’s active pharmaceutical ingredient, “a complex mixture that is the first botanical product to be reviewed by the agency for oral use.”
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