FDA delays action on Salix drug

RALEIGH, N.C. — The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug's manufacturer said.

Salix Pharmaceuticals said the FDA was still reviewing its application for crofelemer in the 125-mg strength. The agency was originally expected to take action on the drug Wednesday. Crofelemer is meant for treating noninfectious diarrhea in HIV and AIDS patients taking antiretroviral therapy.

"By taking no action at this time, the FDA has allowed for the currently ongoing dialogue between Salix and the FDA to continue," Salix EVP medical and research and development and chief development officer Bill Forbes said. "The continuing dialogue should allow further collaboration between us and the agency, a collaboration that has resulted in substantial progress in handling topics important to crofelemer as well as to botanical products in general."


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