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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.”
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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